NDC codes

FDA NDC Directory
Product NDC (as listed)72887-193Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72887-0193Add 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
72887-193-037288701930330 TABLET in 1 BOTTLE, PLASTIC (72887-193-03)Marketed from Jun 3, 2019

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)
oxycodone and acetaminophen
Generic name (nonproprietary)
oxycodone and acetaminophen
Active ingredients
Oxycodone hydrochloride2.5 mg/1Acetaminophen300 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040608
Marketing start
Listing expires
DEA schedule
CII
Other FDA classes
Full Opioid Agonists (Mechanism)
Identifiers
Product ID 72887-193_57ab82a0-2dbe-236b-e063-6394a90a0ab8SPL ID 57ab82a0-2dbe-236b-e063-6394a90a0ab8SPL set ID 88d97caf-bcf5-3cde-e053-2995a90acf4aRxCUI 1014599, 1014615, 1014632, 1037259UNII 362O9ITL9D, C1ENJ2TE6CUPC 0372887193039, 0372887682038, 0372887683035, 0372887681031
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

N472887019303 followed by a unit qualifier and the quantity

Package 72887-0193-03. 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 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over course of therapy [see WARNINGS ], reserve opioid analgesics, including oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040608

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

FDA NDC Directory listings under ANDA 040608
ProductStrengthForm · routeLabelerProduct NDC
oxycodone and acetaminophenoxycodone and acetaminophen tabletsOxycodone hydrochloride 5 mg/1; Acetaminophen 300 mg/1TabletOralFH2 Pharma LLC72887-681
oxycodone and acetaminophenOxycodone hydrochloride 7.5 mg/1; Acetaminophen 300 mg/1TabletOralFH2 Pharma LLC72887-682
oxycodone and acetaminophenoxycodone and acetaminophen tabletsOxycodone hydrochloride 10 mg/1; Acetaminophen 300 mg/1TabletOralFH2 Pharma LLC72887-683
Nalocetoxycodone and acetaminophenOxycodone hydrochloride 2.5 mg/1; Acetaminophen 300 mg/1TabletOralForte Bio-Pharma LLC72245-193
Prolateoxycodone and acetaminophenOxycodone hydrochloride 7.5 mg/1; Acetaminophen 300 mg/1TabletOralForte Bio-Pharma LLC72245-682
Prolateoxycodone and acetaminophenOxycodone hydrochloride 5 mg/1; Acetaminophen 300 mg/1TabletOralForte Bio-Pharma LLC72245-681
Prolateoxycodone and acetaminophenOxycodone hydrochloride 10 mg/1; Acetaminophen 300 mg/1TabletOralForte Bio-Pharma LLC72245-683

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in