NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1420Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1420Add 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
71335-1420-17133514200130 TABLET in 1 BOTTLE (71335-1420-1)Marketed from Apr 24, 2020
71335-1420-271335142002120 TABLET in 1 BOTTLE (71335-1420-2)Marketed from Mar 5, 2020
71335-1420-37133514200390 TABLET in 1 BOTTLE (71335-1420-3)Marketed from Jun 22, 2020
71335-1420-47133514200428 TABLET in 1 BOTTLE (71335-1420-4)Marketed from Apr 3, 2024
71335-1420-57133514200560 TABLET in 1 BOTTLE (71335-1420-5)Marketed from Jan 21, 2020
71335-1420-67133514200620 TABLET in 1 BOTTLE (71335-1420-6)Marketed from Apr 3, 2024
71335-1420-77133514200745 TABLET in 1 BOTTLE (71335-1420-7)Marketed from Sep 21, 2020
71335-1420-87133514200875 TABLET in 1 BOTTLE (71335-1420-8)Marketed from Apr 3, 2024
71335-1420-971335142009100 TABLET in 1 BOTTLE (71335-1420-9)Marketed from Apr 3, 2024

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)
Oxycodone and Acetaminophen
Generic name (nonproprietary)
oxycodone and acetaminophen
Active ingredients
Oxycodone hydrochloride — 10 mg/1Acetaminophen — 325 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201278
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 71335-1420_c99fcf1a-2129-4bf7-90a0-2f351d6c7bb6SPL ID c99fcf1a-2129-4bf7-90a0-2f351d6c7bb6SPL set ID ef2c1fe2-75dd-43cf-871d-540c5e36d363RxCUI 1049214UNII C1ENJ2TE6C, 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

N471335142001 followed by a unit qualifier and the quantity

Package 71335-1420-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Oxycodone and Acetaminophen Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic 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 oxycodone and acetaminophen 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 Oxycodone and acetaminophen tablets should not be used for an extended…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201278

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

FDA NDC Directory listings under ANDA 201278
ProductStrengthForm · routeLabelerProduct NDC
Percocetoxycodone/apapAcetaminophen 325 mg/1; Oxycodone hydrochloride 10 mg/1TabletOralDirect_Rx72189-397
Oxycodone and AcetaminophenOxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack63629-8876
Oxycodone and AcetaminophenOxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack71335-1472
Oxycodone and AcetaminophenOxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack71335-1492
Oxycodone and AcetaminophenOxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack71335-1909
Oxycodone and AcetaminophenOxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1TabletOralProficient Rx LP63187-824
Oxycodone and AcetaminophenOxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-898
Oxycodone and AcetaminophenOxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1TabletOralRhodes Pharmaceuticals LLC42858-104
Oxycodone and AcetaminophenOxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1TabletOralRhodes Pharmaceuticals LLC42858-102
Oxycodone and AcetaminophenOxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1TabletOralRhodes Pharmaceuticals LLC42858-103
Oxycodone and AcetaminophenOxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack63629-9501
Oxycodone and AcetaminophenOxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1TabletOralAsclemed USA, Inc.76420-136
Oxycodone and AcetaminophenOxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1TabletOralRedPharm Drug67296-1937
Oxycodone/APAPOxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1TabletOralDirect_Rx72189-375
Oxycodone and AcetaminophenOxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1TabletOralAsclemed USA, Inc.76420-209
Oxycodone and AcetaminophenOxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack72162-1338
Oxycodone and AcetaminophenOxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1TabletOralBryant Ranch Prepack72162-1339

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