Prescription drug · ANDA
Oxycodone Hydrochloride and Acetaminophen NDC 60760-964
Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · St. Mary's Medical Park Pharmacy
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60760-964-30 | 6076009643060760096430 | 30 TABLET in 1 BOTTLE, PLASTIC (60760-964-30)Marketed from Oct 7, 2025 | |
| 60760-964-60 | 6076009646060760096460 | 60 TABLET in 1 BOTTLE, PLASTIC (60760-964-60)Marketed from Oct 7, 2025 | |
| 60760-964-90 | 6076009649060760096490 | 90 TABLET in 1 BOTTLE, PLASTIC (60760-964-90)Marketed from Oct 28, 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 — 7.5 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- St. Mary's Medical Park PharmacyNDC labeler code 60760
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209385
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 60760-964_59042156-6b2a-5e77-e063-6394a90a86edSPL ID 59042156-6b2a-5e77-e063-6394a90a86edSPL set ID 40a68a27-4422-5ba0-e063-6294a90ac550RxCUI 1049225UNII 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
N460760096430followed by a unit qualifier and the quantityPackage 60760-0964-30. 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 . 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.
About NDC 60760-964
- What is NDC 60760-964?
- 60760-964 is the product NDC for Oxycodone Hydrochloride and Acetaminophen, Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by St. Mary's Medical Park Pharmacy. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oxycodone Hydrochloride and Acetaminophen.
- What is the active ingredient?
- Oxycodone hydrochloride, Acetaminophen.
- Who is the labeler?
- St. Mary's Medical Park Pharmacy, NDC labeler code 60760. 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 Hydrochloride and Acetaminophen?
- 6 other product NDCs are listed under this name. See all Oxycodone Hydrochloride and Acetaminophen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Oxycodone Hydrochloride and Acetaminophen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Oxycodone Hydrochloride and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-963 | 60760-0963-3060760-0963-60 |
| Oxycodone Hydrochloride and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-965 | 60760-0965-3060760-0965-6060760-0965-90 |
| oxycodone hydrochloride and acetaminophen | Oxycodone hydrochloride 10 mg/5mL; Acetaminophen 300 mg/5mL | SolutionOral | FH2 Pharma LLC | 72887-648 | 72887-0648-12 |
| Oxycodone Hydrochloride and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Elite Laboratories, Inc. | 64850-621 | 64850-0621-0164850-0621-05 |
| Oxycodone Hydrochloride and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Elite Laboratories, Inc. | 64850-622 | 64850-0622-0164850-0622-05 |
| Oxycodone Hydrochloride and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Elite Laboratories, Inc. | 64850-623 | 64850-0623-0164850-0623-05 |
Other NDCs under ANDA 209385
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| 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 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-965 |
| 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 |