Prescription drug · ANDA
Endocet NDC 63629-2190
oxycodone and acetaminophen · Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2190-1 | 63629219001 | 100 TABLET in 1 BOTTLE, PLASTIC (63629-2190-1)Marketed from Aug 8, 2024 |
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)
- Endocet
- Generic name (nonproprietary)
- oxycodone and acetaminophen
- Active ingredients
- Oxycodone hydrochloride — 7.5 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040330
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 63629-2190_3b8ef94a-da42-46b5-9fa9-2fac9ed6e7c3SPL ID 3b8ef94a-da42-46b5-9fa9-2fac9ed6e7c3SPL set ID 3b8ef94a-da42-46b5-9fa9-2fac9ed6e7c3RxCUI 1049225, 1049227UNII 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
N463629219001followed by a unit qualifier and the quantityPackage 63629-2190-01. 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, and misuse with opioids, which can occur at any dosage or duration [see WARNINGS ] , reserve ENDOCET 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 ENDOCET should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and…
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 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 | Par Health USA, LLC | 60951-712 |
| 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 |