Prescription drug · ANDA
Prolate NDC 72245-683
oxycodone and acetaminophen · Oxycodone hydrochloride 10 mg/1; Acetaminophen 300 mg/1 · Tablet · Oral · Forte Bio-Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72245-683-03 | 72245068303 | 30 TABLET in 1 BOTTLE, PLASTIC (72245-683-03)Marketed from Feb 17, 2020 | |
| 72245-683-10 | 72245068310 | 100 TABLET in 1 BOTTLE, PLASTIC (72245-683-10)Marketed from Feb 17, 2020 |
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)
- Prolate
- Generic name (nonproprietary)
- oxycodone and acetaminophen
- Active ingredients
- Oxycodone hydrochloride — 10 mg/1Acetaminophen — 300 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Forte Bio-Pharma LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040608
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 72245-683_522d935a-3cf8-b78a-e063-6294a90a4343SPL ID 522d935a-3cf8-b78a-e063-6294a90a4343SPL set ID 9cbbfa94-37b9-9652-e053-2995a90a736bRxCUI 1014599, 1014615, 1014632, 2279510, 2279512, 2279514UNII 362O9ITL9D, C1ENJ2TE6CUPC 0372245682106, 0372245681109, 0372245683103
- 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
N472245068303followed by a unit qualifier and the quantityPackage 72245-0683-03. 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 are 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 course of therapy [see WARNINGS ], reserve opioid analgesics, including oxycodone and acetaminophen tablets, 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 040608
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 acetaminophenoxycodone and acetaminophen tablets | Oxycodone hydrochloride 5 mg/1; Acetaminophen 300 mg/1 | TabletOral | FH2 Pharma LLC | 72887-681 |
| oxycodone and acetaminophen | Oxycodone hydrochloride 2.5 mg/1; Acetaminophen 300 mg/1 | TabletOral | FH2 Pharma LLC | 72887-193 |
| oxycodone and acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 300 mg/1 | TabletOral | FH2 Pharma LLC | 72887-682 |
| oxycodone and acetaminophenoxycodone and acetaminophen tablets | Oxycodone hydrochloride 10 mg/1; Acetaminophen 300 mg/1 | TabletOral | FH2 Pharma LLC | 72887-683 |
| Nalocetoxycodone and acetaminophen | Oxycodone hydrochloride 2.5 mg/1; Acetaminophen 300 mg/1 | TabletOral | Forte Bio-Pharma LLC | 72245-193 |
| Prolateoxycodone and acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 300 mg/1 | TabletOral | Forte Bio-Pharma LLC | 72245-682 |
| Prolateoxycodone and acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 300 mg/1 | TabletOral | Forte Bio-Pharma LLC | 72245-681 |