Prescription drug · ANDA
Oxycodone and Acetaminophen NDC 67296-1937
Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · RedPharm Drug
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67296-1937-0 | 67296193700 | 4 TABLET in 1 BOTTLE (67296-1937-0)Marketed from Aug 28, 2014 | |
| 67296-1937-1 | 67296193701 | 10 TABLET in 1 BOTTLE (67296-1937-1)Marketed from Aug 28, 2014 | |
| 67296-1937-2 | 67296193702 | 20 TABLET in 1 BOTTLE (67296-1937-2)Marketed from Aug 28, 2014 | |
| 67296-1937-3 | 67296193703 | 12 TABLET in 1 BOTTLE (67296-1937-3)Marketed from Aug 28, 2014 | |
| 67296-1937-6 | 67296193706 | 6 TABLET in 1 BOTTLE (67296-1937-6)Marketed from Aug 28, 2014 | |
| 67296-1937-7 | 67296193707 | 15 TABLET in 1 BOTTLE (67296-1937-7)Marketed from Aug 28, 2014 |
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
- RedPharm Drug
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201278
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 67296-1937_46c2006d-2f29-71c8-e063-6294a90a72a2SPL ID 46c2006d-2f29-71c8-e063-6294a90a72a2SPL set ID 2c6014de-8901-9d83-e063-6294a90ad37bRxCUI 1049221UNII 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
N467296193700followed by a unit qualifier and the quantityPackage 67296-1937-00. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Oxycodone and Acetaminophen Tablets, USP 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 or opioid combination products]: 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 sho…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201278
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 |
|---|---|---|---|---|
| Percocetoxycodone/apap | Acetaminophen 325 mg/1; Oxycodone hydrochloride 10 mg/1 | TabletOral | Direct_Rx | 72189-397 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1420 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8876 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1472 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1492 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1909 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Proficient Rx LP | 63187-824 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-898 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-104 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-102 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-103 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9501 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-136 |
| Oxycodone/APAP | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Direct_Rx | 72189-375 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-209 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1338 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1339 |