Over-the-counter drug · ANDA
Acetaminophen and Ibuprofen Back Pain (Acetaminophen and ibuprofen) NDC 58602-895
Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 · Tablet, Film coated · Oral · Aurohealth LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)58602-895Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58602-0895Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58602-895-01 | 58602089501 | 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-01) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Mar 26, 2024 | |
| 58602-895-03 | 58602089503 | 1 BOTTLE in 1 CARTON (58602-895-03) / 10 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 26, 2024 | |
| 58602-895-07 | 58602089507 | 1 BOTTLE in 1 CARTON (58602-895-07) / 24 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 26, 2024 | |
| 58602-895-11 | 58602089511 | 1 BOTTLE in 1 CARTON (58602-895-11) / 36 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 26, 2024 | |
| 58602-895-14 | 58602089514 | 1 BOTTLE in 1 CARTON (58602-895-14) / 50 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 26, 2024 | |
| 58602-895-21 | 58602089521 | 1 BOTTLE in 1 CARTON (58602-895-21) / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 26, 2024 | |
| 58602-895-29 | 58602089529 | 1 BOTTLE in 1 CARTON (58602-895-29) / 150 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 26, 2024 | |
| 58602-895-35 | 58602089535 | 225 TABLET, FILM COATED in 1 BOTTLE (58602-895-35)Marketed from Mar 26, 2024 | |
| 58602-895-40 | 58602089540 | 500 TABLET, FILM COATED in 1 BOTTLE (58602-895-40)Marketed from Mar 26, 2024 | |
| 58602-895-41 | 58602089541 | 1000 TABLET, FILM COATED in 1 BOTTLE (58602-895-41)Marketed from Mar 26, 2024 | |
| 58602-895-44 | 58602089544 | 400 TABLET, FILM COATED in 1 BOTTLE (58602-895-44)Marketed from Mar 26, 2024 | |
| 58602-895-46 | 58602089546 | 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-46) / 18 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Mar 26, 2024 | |
| 58602-895-49 | 58602089549 | 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-49) / 10 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Mar 26, 2024 | |
| 58602-895-51 | 58602089551 | 216 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-51)Marketed from Mar 26, 2024 | |
| 58602-895-61 | 58602089561 | 1 BLISTER PACK in 1 CARTON (58602-895-61) / 2 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Mar 26, 2024 | |
| 58602-895-62 | 58602089562 | 216 TABLET, FILM COATED in 1 BOTTLE (58602-895-62)Marketed from Mar 26, 2024 | |
| 58602-895-65 | 58602089565 | 1 BOTTLE in 1 CARTON (58602-895-65) / 72 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 26, 2024 | |
| 58602-895-73 | 58602089573 | 1 BOTTLE in 1 CARTON (58602-895-73) / 20 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 26, 2024 | |
| 58602-895-78 | 58602089578 | 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-78) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Mar 26, 2024 | |
| 58602-895-79 | 58602089579 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-79)Marketed from Mar 26, 2024 | |
| 58602-895-80 | 58602089580 | 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-80) / 72 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Mar 26, 2024 | |
| 58602-895-82 | 58602089582 | 1 BOTTLE in 1 CARTON (58602-895-82) / 18 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 26, 2024 | |
| 58602-895-84 | 58602089584 | 225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-84)Marketed from Mar 26, 2024 | |
| 58602-895-85 | 58602089585 | 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-85) / 36 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Mar 26, 2024 | |
| 58602-895-88 | 58602089588 | 750 TABLET, FILM COATED in 1 BOTTLE (58602-895-88)Marketed from Mar 26, 2024 | |
| 58602-895-94 | 58602089594 | 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-94) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Mar 26, 2024 | |
| 58602-895-95 | 58602089595 | 750 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-95)Marketed from Mar 26, 2024 | |
| 58602-895-96 | 58602089596 | 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-96) / 20 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Mar 26, 2024 | |
| 58602-895-99 | 58602089599 | 400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-895-99)Marketed from Mar 26, 2024 |
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 Ibuprofen Back Pain
- Generic name (nonproprietary)
- acetaminophen and ibuprofen
- Active ingredients
- Acetaminophen — 250 mg/1Ibuprofen — 125 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurohealth LLCNDC labeler code 58602
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218359
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 58602-895_358fae0b-3a56-4ffa-ba09-de83cd8200a5SPL ID 358fae0b-3a56-4ffa-ba09-de83cd8200a5SPL set ID 62d7ce90-63a4-4383-87c9-3a458eac29bfRxCUI 2387532UNII 362O9ITL9D, WK2XYI10QM
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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
N458602089501followed by a unit qualifier and the quantityPackage 58602-0895-01. 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 .
Indications (excerpt from the label)
Uses temporarily relieves minor aches and pains due to: backache muscular aches minor pain of arthritis headache toothache menstrual cramps
Excerpt only. Read the full label for complete information.
About NDC 58602-895
- What is NDC 58602-895?
- 58602-895 is the product NDC for Acetaminophen and Ibuprofen Back Pain, Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 tablet, film coated, listed with the FDA by Aurohealth LLC. It has 29 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acetaminophen and Ibuprofen Back Pain (Acetaminophen and Ibuprofen).
- What is the active ingredient?
- Acetaminophen, Ibuprofen.
- Who is the labeler?
- Aurohealth LLC, NDC labeler code 58602. 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 Ibuprofen Back Pain?
- 1 other product NDC are listed under this name. See all Acetaminophen and Ibuprofen Back Pain 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 Ibuprofen Back Pain 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 Ibuprofen Back Painacetaminophen and ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-213 | 70010-0213-2670010-0213-31 |
Other NDCs under ANDA 218359
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 Ibuprofen | Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 | Tablet, Film coatedOral | Aurohealth LLC | 58602-893 |