Prescription drug · ANDA
Oxycodone/APAP NDC 72189-375
Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-375-30 | 72189037530 | 30 TABLET in 1 BOTTLE (72189-375-30)Marketed from Sep 9, 2022 | |
| 72189-375-60 | 72189037560 | 60 TABLET in 1 BOTTLE (72189-375-60)Marketed from Sep 9, 2022 | |
| 72189-375-72 | 72189037572 | 120 TABLET in 1 BOTTLE (72189-375-72)Marketed from Sep 9, 2022 | |
| 72189-375-90 | 72189037590 | 90 TABLET in 1 BOTTLE (72189-375-90)Marketed from Sep 9, 2022 |
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/APAP
- Generic name (nonproprietary)
- oxycodone/apap
- Active ingredients
- Oxycodone hydrochloride — 7.5 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Direct_Rx
- 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 72189-375_4c4c55ca-eef7-8b39-e063-6294a90adf3fSPL ID 4c4c55ca-eef7-8b39-e063-6294a90adf3fSPL set ID e84245ca-957f-e85b-e053-2a95a90a836bRxCUI 1049225UNII 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
N472189037530followed by a unit qualifier and the quantityPackage 72189-0375-30. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | RedPharm Drug | 67296-1937 |
| 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 |