Oxycodone Hydrochloride and Acetaminophen NDC 60760-965

NDC codes

FDA NDC Directory

Product NDC (as listed)60760-965Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60760-0965Add 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
60760-965-30	60760096530	30 TABLET in 1 BOTTLE, PLASTIC (60760-965-30)Marketed from Jul 7, 2026
60760-965-60	60760096560	60 TABLET in 1 BOTTLE, PLASTIC (60760-965-60)Marketed from Oct 7, 2025
60760-965-90	60760096590	90 TABLET in 1 BOTTLE, PLASTIC (60760-965-90)Marketed from Oct 7, 2025

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 Hydrochloride and Acetaminophen
Generic name (nonproprietary): oxycodone hydrochloride and acetaminophen
Active ingredients: Oxycodone hydrochloride — 10 mg/1Acetaminophen — 325 mg/1
Dosage form: Tablet
Route: Oral
Labeler: St. Mary's Medical Park Pharmacy
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209385
Marketing start: Oct 7, 2025
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 60760-965_569ea8dc-f901-139b-e063-6294a90ae8a6SPL ID 569ea8dc-f901-139b-e063-6294a90ae8a6SPL set ID 40a882d6-a4db-1ad9-e063-6394a90a7268RxCUI 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

N460760096530 followed by a unit qualifier and the quantity

Package 60760-0965-30. 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 Jul 14, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS & 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, 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 per…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209385

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

FDA NDC Directory listings under ANDA 209385
Product	Strength	Form · route	Labeler	Product NDC
Oxycodone Hydrochloride and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Elite Laboratories, Inc.	64850-621
Oxycodone Hydrochloride and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Elite Laboratories, Inc.	64850-622
Oxycodone Hydrochloride and Acetaminophen	Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Elite Laboratories, Inc.	64850-623
Oxycodone Hydrochloride and Acetaminophen	Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-963
Oxycodone Hydrochloride and Acetaminophen	Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-964