Prescription drug · ANDA
Percocet NDC 63481-629
oxycodone hydrochloride and acetaminophen · Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · SpecGx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63481-629-70 | 6348106297063481062970 | 100 TABLET in 1 BOTTLE (63481-629-70)Marketed from Nov 30, 2001 |
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)
- Percocet
- Generic name (nonproprietary)
- oxycodone hydrochloride and acetaminophen
- Active ingredients
- Oxycodone hydrochloride — 10 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- SpecGx LLCNDC labeler code 63481
- 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 63481-629_00fce06a-499a-47fa-a583-ad8cf849f43dSPL ID 00fce06a-499a-47fa-a583-ad8cf849f43d
- 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
N463481062970followed by a unit qualifier and the quantityPackage 63481-0629-70. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 63481-629
- What is NDC 63481-629?
- 63481-629 is the product NDC for Percocet, Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by SpecGx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Percocet (Oxycodone hydrochloride and acetaminophen).
- What is the active ingredient?
- Oxycodone hydrochloride, Acetaminophen.
- Who is the labeler?
- SpecGx LLC, NDC labeler code 63481. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Percocet?
- 3 other product NDCs are listed under this name. See all Percocet NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Percocet products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Percocetoxycodone/apap | Acetaminophen 325 mg/1; Oxycodone hydrochloride 10 mg/1 | TabletOral | Direct_Rx | 72189-397 | 72189-0397-3072189-0397-6072189-0397-72 |
| Percocetoxycodone hydrochloride and acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | SpecGx LLC | 63481-628 | 63481-0628-70 |
| Percocetoxycodone hydrochloride and acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | SpecGx LLC | 63481-623 | 63481-0623-70 |
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 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 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2190 |
| Endocetoxycodone and acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Redpharm Drug | 67296-0836 |
| Endocetoxycodone and acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2182 |
| Endocetoxycodone and acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1728 |
| 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 |