Prescription drug · ANDA
Acetaminophen And Codeine Phosphate NDC 67544-002
Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)67544-002Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67544-0002Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67544-002-09 | 6754400020967544000209 | 9 TABLET in 1 BOTTLE, PLASTIC (67544-002-09)Marketed from Jul 6, 2011 | |
| 67544-002-15 | 6754400021567544000215 | 15 TABLET in 1 BOTTLE, PLASTIC (67544-002-15)Marketed from Jul 6, 2011 | |
| 67544-002-20 | 6754400022067544000220 | 20 TABLET in 1 BOTTLE, PLASTIC (67544-002-20)Marketed from Jul 6, 2011 | |
| 67544-002-30 | 6754400023067544000230 | 30 TABLET in 1 BOTTLE, PLASTIC (67544-002-30)Marketed from Jul 6, 2011 | |
| 67544-002-40 | 6754400024067544000240 | 40 TABLET in 1 BOTTLE, PLASTIC (67544-002-40)Marketed from Jul 6, 2011 | |
| 67544-002-45 | 6754400024567544000245 | 45 TABLET in 1 BOTTLE, PLASTIC (67544-002-45)Marketed from Jul 6, 2011 | |
| 67544-002-46 | 6754400024667544000246 | 56 TABLET in 1 BOTTLE, PLASTIC (67544-002-46)Marketed from Jul 28, 2021 | |
| 67544-002-50 | 6754400025067544000250 | 50 TABLET in 1 BOTTLE, PLASTIC (67544-002-50)Marketed from Jul 6, 2011 | |
| 67544-002-53 | 6754400025367544000253 | 60 TABLET in 1 BOTTLE, PLASTIC (67544-002-53)Marketed from Jul 6, 2011 | |
| 67544-002-54 | 6754400025467544000254 | 84 TABLET in 1 BOTTLE, PLASTIC (67544-002-54)Marketed from Aug 4, 2021 | |
| 67544-002-55 | 6754400025567544000255 | 75 TABLET in 1 BOTTLE, PLASTIC (67544-002-55)Marketed from Jul 6, 2011 | |
| 67544-002-60 | 6754400026067544000260 | 90 TABLET in 1 BOTTLE, PLASTIC (67544-002-60)Marketed from Jul 6, 2011 | |
| 67544-002-70 | 6754400027067544000270 | 120 TABLET in 1 BOTTLE, PLASTIC (67544-002-70)Marketed from Jul 6, 2011 | |
| 67544-002-72 | 6754400027267544000272 | 112 TABLET in 1 BOTTLE, PLASTIC (67544-002-72)Marketed from Aug 10, 2021 | |
| 67544-002-75 | 6754400027567544000275 | 150 TABLET in 1 BOTTLE, PLASTIC (67544-002-75)Marketed from Jul 6, 2011 | |
| 67544-002-80 | 6754400028067544000280 | 180 TABLET in 1 BOTTLE, PLASTIC (67544-002-80)Marketed from Jul 6, 2011 | |
| 67544-002-85 | 6754400028567544000285 | 200 TABLET in 1 BOTTLE, PLASTIC (67544-002-85)Marketed from Jul 6, 2011 | |
| 67544-002-90 | 6754400029067544000290 | 240 TABLET in 1 BOTTLE, PLASTIC (67544-002-90)Marketed from Jul 6, 2011 | |
| 67544-002-93 | 6754400029367544000293 | 300 TABLET in 1 BOTTLE, PLASTIC (67544-002-93)Marketed from Jul 6, 2011 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Acetaminophen And Codeine Phosphate
- Generic name (nonproprietary)
- acetaminophen and codeine phosphate
- Active ingredients
- Acetaminophen — 300 mg/1Codeine phosphate — 30 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 67544
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040419
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 67544-002_c4cf2f28-c73e-4370-843e-487b7b42e077SPL ID c4cf2f28-c73e-4370-843e-487b7b42e077SPL set ID d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1RxCUI 993770, 993781, 993890UNII GSL05Y1MN6, 362O9ITL9D
- Pharmacologic class
- Opioid Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N467544000209followed by a unit qualifier and the quantityPackage 67544-0002-09. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain.
Excerpt only. Read the full label for complete information.
About NDC 67544-002
- What is NDC 67544-002?
- 67544-002 is the product NDC for Acetaminophen And Codeine Phosphate, Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 19 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acetaminophen And Codeine Phosphate.
- What is the active ingredient?
- Acetaminophen, Codeine phosphate.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 67544. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acetaminophen And Codeine Phosphate?
- 67 other product NDCs are listed under this name. See all Acetaminophen And Codeine Phosphate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Acetaminophen And Codeine Phosphate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-009 | 87441-0009-01 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8881 | 68788-8881-0168788-8881-0368788-8881-06 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8882 | 68788-8882-0168788-8882-0368788-8882-06 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0527 | 80425-0527-0180425-0527-0280425-0527-03 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0528 | 80425-0528-0180425-0528-0280425-0528-03 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0529 | 80425-0529-0180425-0529-0280425-0529-03 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0530 | 80425-0530-0180425-0530-0280425-0530-03 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4104 | 70518-4104-00 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-938 | 60760-0938-30 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-446 | 64380-0446-0164380-0446-0264380-0446-03 |
Other NDCs under ANDA 040419
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Clinical Solutions Wholesale, LLC | 58118-0485 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1522 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Clinical Solutions Wholesale, LLC | 58118-4484 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7835 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | A-S Medication Solutions | 50090-3011 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Proficient Rx LP | 63187-106 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7859 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 15 mg/1 | TabletOral | SpecGx LLC | 0406-0483 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 67544-003 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | SpecGx LLC | 0406-0484 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-009 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-581 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-3031 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | A-S Medication Solutions | 50090-4610 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3705 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | SpecGx LLC | 0406-0485 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | A-S Medication Solutions | 50090-4611 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4475 |
| Acetaminophen And Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4533 |
| Acetaminophen and Codeine Phosphate | Acetaminophen 300 mg/1; Codeine phosphate 60 mg/1 | TabletOral | Direct_Rx | 72189-376 |
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