Oxycodone and Acetaminophen NDC 63187-721

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-721Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0721Add 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 NDC	11-digit (billing)	Package
63187-721-15	63187072115	15 TABLET in 1 BOTTLE (63187-721-15)Marketed from Jun 1, 2016
63187-721-20	63187072120	20 TABLET in 1 BOTTLE (63187-721-20)Marketed from Jun 1, 2016
63187-721-30	63187072130	30 TABLET in 1 BOTTLE (63187-721-30)Marketed from Jun 1, 2016
63187-721-60	63187072160	60 TABLET in 1 BOTTLE (63187-721-60)Marketed from Jun 1, 2016
63187-721-90	63187072190	90 TABLET in 1 BOTTLE (63187-721-90)Marketed from May 30, 2017

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 hydrochloride — 10 mg/1Acetaminophen — 325 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Proficient Rx LP
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040778
Marketing start: Nov 27, 2007
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 63187-721_b6da114d-fc88-4f72-9055-a963b4625f25SPL ID b6da114d-fc88-4f72-9055-a963b4625f25SPL set ID 6253b3ae-bb52-4532-8d1f-756c0b1577c7RxCUI 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

N463187072115 followed by a unit qualifier and the quantity

Package 63187-0721-15. 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 Nov 1, 2019.

Indications (excerpt from the label)

INDICATIONS AND USAGE Oxycodone and Acetaminophen Tablets, USP are indicated for the relief of moderate to moderately severe pain.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040778

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

FDA NDC Directory listings under ANDA 040778
Product	Strength	Form · route	Labeler	Product NDC
Oxycodone and Acetaminophen	Acetaminophen 325 mg/1; Oxycodone hydrochloride 10 mg/1	TabletOral	AvPAK	50268-646
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	AvPAK	50268-645
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-204
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Amneal Pharmaceuticals LLC	65162-207