Prescription drug · ANDA
Oxycodone and Acetaminophen NDC 63187-363
Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-363-12 | 63187036312 | 12 TABLET in 1 BOTTLE (63187-363-12)Marketed from Nov 1, 2016 | |
| 63187-363-15 | 63187036315 | 15 TABLET in 1 BOTTLE (63187-363-15)Marketed from Aug 1, 2016 | |
| 63187-363-20 | 63187036320 | 20 TABLET in 1 BOTTLE (63187-363-20)Marketed from Aug 1, 2016 | |
| 63187-363-30 | 63187036330 | 30 TABLET in 1 BOTTLE (63187-363-30)Marketed from Aug 1, 2016 | |
| 63187-363-60 | 63187036360 | 60 TABLET in 1 BOTTLE (63187-363-60)Marketed from Aug 1, 2016 |
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 and Acetaminophen
- Generic name (nonproprietary)
- oxycodone and acetaminophen
- Active ingredients
- Oxycodone hydrochloride — 10 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202677
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 63187-363_b9d14bcb-219d-406c-85c5-405c9e8b8508SPL ID b9d14bcb-219d-406c-85c5-405c9e8b8508SPL set ID 0233de1c-466b-4842-8604-6d879aa36a4bRxCUI 1049214, 1049221UNII 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
N463187036312followed by a unit qualifier and the quantityPackage 63187-0363-12. 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 is indicated for the relief of moderate to moderately severe pain.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202677
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 and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0316 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Alvogen, Inc. | 47781-229 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Alvogen, Inc. | 47781-196 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Alvogen, Inc. | 47781-230 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Proficient Rx LP | 63187-719 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | American Health Packaging | 68084-699 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3683 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | American Health Packaging | 68084-710 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-899 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-897 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0146 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0216 |