NDC codes

FDA NDC Directory
Product NDC (as listed)71335-0256Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0256Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
71335-0256-0713350256007133502560040 TABLET in 1 BOTTLE (71335-0256-0)Marketed from Aug 9, 2024
71335-0256-171335025601713350256016 TABLET in 1 BOTTLE (71335-0256-1)Marketed from Jan 31, 2019
71335-0256-2713350256027133502560220 TABLET in 1 BOTTLE (71335-0256-2)Marketed from Apr 6, 2018
71335-0256-3713350256037133502560330 TABLET in 1 BOTTLE (71335-0256-3)Marketed from Mar 20, 2018
71335-0256-4713350256047133502560484 TABLET in 1 BOTTLE (71335-0256-4)Marketed from Aug 9, 2024
71335-0256-5713350256057133502560515 TABLET in 1 BOTTLE (71335-0256-5)Marketed from Apr 23, 2018
71335-0256-67133502560671335025606120 TABLET in 1 BOTTLE (71335-0256-6)Marketed from Mar 6, 2018
71335-0256-77133502560771335025607100 TABLET in 1 BOTTLE (71335-0256-7)Marketed from Aug 9, 2024
71335-0256-8713350256087133502560860 TABLET in 1 BOTTLE (71335-0256-8)Marketed from Mar 1, 2018
71335-0256-9713350256097133502560990 TABLET in 1 BOTTLE (71335-0256-9)Marketed from Feb 28, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202800
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 71335-0256_a26a78cb-5b57-4011-88bf-c552c9e1af6dSPL ID a26a78cb-5b57-4011-88bf-c552c9e1af6dSPL set ID 30da1bea-2dbc-4086-a5cf-8ed471bb6593RxCUI 993781UNII 362O9ITL9D, GSL05Y1MN6
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

N471335025600 followed by a unit qualifier and the quantity

Package 71335-0256-00. 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 management of mild to moderate pain,where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see WARNINGS ], reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] · Have not been tolerated or are not expected to be tolerated. · Have not provided adequate analgesia or are not expected to provide adequate analgesia, Acetaminophen and codeine phosphate t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-0256

What is NDC 71335-0256?
71335-0256 is the product NDC for Acetaminophen and Codeine Phosphate, Acetaminophen 300 mg/1; Codeine phosphate 30 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Acetaminophen and Codeine Phosphate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Acetaminophen And Codeine PhosphateAcetaminophen 300 mg/1; Codeine phosphate 30 mg/1TabletOralUnit Dose Solutions, Inc.87441-00987441-0009-01
Acetaminophen and Codeine PhosphateAcetaminophen 300 mg/1; Codeine phosphate 60 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-888168788-8881-0168788-8881-0368788-8881-06
Acetaminophen And Codeine PhosphateAcetaminophen 300 mg/1; Codeine phosphate 60 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-888268788-8882-0168788-8882-0368788-8882-06
Acetaminophen and Codeine PhosphateAcetaminophen 300 mg/1; Codeine phosphate 30 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-052780425-0527-0180425-0527-0280425-0527-03
Acetaminophen and Codeine PhosphateAcetaminophen 300 mg/1; Codeine phosphate 60 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-052880425-0528-0180425-0528-0280425-0528-03
Acetaminophen and Codeine PhosphateAcetaminophen 300 mg/1; Codeine phosphate 30 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-052980425-0529-0180425-0529-0280425-0529-03
Acetaminophen and Codeine PhosphateAcetaminophen 300 mg/1; Codeine phosphate 60 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-053080425-0530-0180425-0530-0280425-0530-03
Acetaminophen and Codeine PhosphateAcetaminophen 300 mg/1; Codeine phosphate 30 mg/1TabletOralREMEDYREPACK INC.70518-410470518-4104-00
Acetaminophen and Codeine PhosphateAcetaminophen 300 mg/1; Codeine phosphate 30 mg/1TabletOralST. MARY'S MEDICAL PARK PHARMACY60760-93860760-0938-30
Acetaminophen and Codeine PhosphateAcetaminophen 300 mg/1; Codeine phosphate 30 mg/1TabletOralStrides Pharma Science Limited64380-44664380-0446-0164380-0446-0264380-0446-03

All 68 Acetaminophen and Codeine Phosphate NDCs

Other NDCs under ANDA 202800

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 202800
ProductStrengthForm · routeLabelerProduct NDC
Acetaminophen and Codeine PhosphateAcetaminophen 300 mg/1; Codeine phosphate 30 mg/1TabletOralProficient Rx LP63187-815
Acetaminophen and Codeine PhosphateAcetaminophen 300 mg/1; Codeine phosphate 30 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-5010
Acetaminophen and Codeine PhosphateAcetaminophen 300 mg/1; Codeine phosphate 15 mg/1TabletOralAurolife Pharma, LLC13107-058
Acetaminophen and Codeine PhosphateAcetaminophen 300 mg/1; Codeine phosphate 30 mg/1TabletOralAurolife Pharma, LLC13107-059
Acetaminophen and Codeine PhosphateAcetaminophen 300 mg/1; Codeine phosphate 60 mg/1TabletOralAurolife Pharma, LLC13107-060
Acetaminophen and Codeine PhosphateAcetaminophen 300 mg/1; Codeine phosphate 60 mg/1TabletOralBryant Ranch Prepack71335-0336
Acetaminophen and Codeine PhosphateAcetaminophen 300 mg/1; Codeine phosphate 30 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4673
Acetaminophen and Codeine PhosphateAcetaminophen 300 mg/1; Codeine phosphate 60 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4749

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