What is NDC 71335-0216?

71335-0216 is the product NDC for Oxycodone and Acetaminophen, Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 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 is the active ingredient?

Oxycodone hydrochloride, Acetaminophen.

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 Oxycodone and Acetaminophen?

110 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Oxycodone and Acetaminophen NDC 71335-0216

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-0216Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-0216Add 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
71335-0216-0	7133502160071335021600	25 TABLET in 1 BOTTLE (71335-0216-0)Marketed from Jul 25, 2016
71335-0216-1	7133502160171335021601	10 TABLET in 1 BOTTLE (71335-0216-1)Marketed from Jul 25, 2016
71335-0216-2	7133502160271335021602	120 TABLET in 1 BOTTLE (71335-0216-2)Marketed from Jul 25, 2016
71335-0216-3	7133502160371335021603	28 TABLET in 1 BOTTLE (71335-0216-3)Marketed from Jul 25, 2016
71335-0216-4	7133502160471335021604	12 TABLET in 1 BOTTLE (71335-0216-4)Marketed from Jul 25, 2016
71335-0216-5	7133502160571335021605	40 TABLET in 1 BOTTLE (71335-0216-5)Marketed from Jul 25, 2016
71335-0216-6	7133502160671335021606	30 TABLET in 1 BOTTLE (71335-0216-6)Marketed from Jul 25, 2016
71335-0216-7	7133502160771335021607	90 TABLET in 1 BOTTLE (71335-0216-7)Marketed from Jul 25, 2016
71335-0216-8	7133502160871335021608	60 TABLET in 1 BOTTLE (71335-0216-8)Marketed from Jul 25, 2016
71335-0216-9	7133502160971335021609	84 TABLET in 1 BOTTLE (71335-0216-9)Marketed from Jul 25, 2016

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 — 5 mg/1Acetaminophen — 325 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 202677
Marketing start: Mar 9, 2016
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 71335-0216_68226f26-8369-4b58-a0e9-e9b943a8df09SPL ID 68226f26-8369-4b58-a0e9-e9b943a8df09SPL set ID b4cf62af-b5d3-4825-9743-9ec3137164e8RxCUI 1049214, 1049221, 1049225UNII 362O9ITL9D, C1ENJ2TE6C
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

N471335021600 followed by a unit qualifier and the quantity

Package 71335-0216-00. 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 Oct 8, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Oxycodone and acetaminophen tablets is 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, even at recommended doses [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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-0216

What is NDC 71335-0216?: 71335-0216 is the product NDC for Oxycodone and Acetaminophen, Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 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?: Oxycodone and Acetaminophen.
What is the active ingredient?: Oxycodone hydrochloride, Acetaminophen.
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 Oxycodone and Acetaminophen?: 110 other product NDCs are listed under this name. See all Oxycodone and Acetaminophen 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 Oxycodone and Acetaminophen NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-898	60760-0898-3060760-0898-60
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-899	60760-0899-3060760-0899-6060760-0899-90
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-897	60760-0897-3060760-0897-60
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Direct_Rx	72189-368	72189-0368-3072189-0368-6072189-0368-72+1 more
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	American Health Packaging	60687-642	60687-0642-01
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Granules Pharmaceuticals Inc.	70010-668	70010-0668-0170010-0668-05
Oxycodone and Acetaminophen	Acetaminophen 325 mg/1; Oxycodone hydrochloride 2.5 mg/1	TabletOral	Granules Pharmaceuticals Inc.	70010-667	70010-0667-0170010-0667-05
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Granules Pharmaceuticals Inc.	70010-669	70010-0669-0170010-0669-05
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Granules Pharmaceuticals Inc.	70010-670	70010-0670-0170010-0670-05
Oxycodone And Acetaminophen	Acetaminophen 325 mg/1; Oxycodone hydrochloride 7.5 mg/1	TabletOral	DIRECT RX	72189-256	72189-0256-3072189-0256-6072189-0256-72

All 111 Oxycodone and Acetaminophen NDCs

Other NDCs under ANDA 202677

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

FDA NDC Directory listings under ANDA 202677
Product	Strength	Form · route	Labeler	Product NDC
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Alvogen, Inc.	47781-196
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Alvogen, Inc.	47781-229
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Alvogen, Inc.	47781-230
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-897
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-899
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Proficient Rx LP	63187-363
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Proficient Rx LP	63187-719
Oxycodone and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3683
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	American Health Packaging	68084-699
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	American Health Packaging	68084-710
Oxycodone and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-0146
Oxycodone and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-0316