Prescription drug · ANDA
Endocet NDC 60951-712
oxycodone and acetaminophen · Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60951-712-70 | 60951071270 | 100 TABLET in 1 BOTTLE (60951-712-70)Marketed from Mar 6, 2003 |
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)
- Endocet
- Generic name (nonproprietary)
- oxycodone and acetaminophen
- Active ingredients
- Oxycodone hydrochloride — 10 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Par Health USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040330
- Marketing start
- Marketing end
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 60951-712_a8475489-982f-4080-9565-7948155d9abbSPL ID a8475489-982f-4080-9565-7948155d9abbSPL set ID 944d3e60-7eee-11de-a413-0002a5d5c51bRxCUI 1049214, 1049216, 1049221, 1049223, 1049225, 1049227, 1049635, 1487288UNII 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
N460951071270followed by a unit qualifier and the quantityPackage 60951-0712-70. 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 ENDOCET 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including ENDOCET, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040330
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 |
|---|---|---|---|---|
| Endocetoxycodone and acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2190 |
| Endocetoxycodone and acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2182 |
| Endocetoxycodone and acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Redpharm Drug | 67296-0836 |
| Endocetoxycodone and acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Par Health USA, LLC | 60951-602 |
| Endocetoxycodone and acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Par Health USA, LLC | 60951-700 |
| Endocetoxycodone and acetaminophen | Oxycodone hydrochloride 2.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Par Health USA, LLC | 60951-701 |
| Endocetoxycodone and acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1728 |
| Percocetoxycodone hydrochloride and acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | SpecGx LLC | 63481-629 |
| Percocetoxycodone hydrochloride and acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | SpecGx LLC | 63481-623 |
| Percocetoxycodone hydrochloride and acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | SpecGx LLC | 63481-628 |