Prescription drug · ANDA
Oxycodone and Acetaminophen NDC 31722-194
Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-194-01 | 31722019401 | 100 TABLET in 1 BOTTLE (31722-194-01)Marketed from Apr 11, 2017 | |
| 31722-194-05 | 31722019405 | 500 TABLET in 1 BOTTLE (31722-194-05)Marketed from Apr 11, 2017 |
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
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207419
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 31722-194_560e8cac-91f2-47dc-ac17-4d511598c49aSPL ID 560e8cac-91f2-47dc-ac17-4d511598c49aSPL set ID 2a49ee34-6f1d-4ed3-8daa-343723d2a2beRxCUI 1049214, 1049221, 1049225, 1049635UNII 362O9ITL9D, C1ENJ2TE6CUPC 0331722194013, 0331722191012, 0331722192019
- 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
N431722019401followed by a unit qualifier and the quantityPackage 31722-0194-01. 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 Oxycodone and Acetaminophen Tablets 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, even at recommended doses [see WARNINGS], reserve Oxycodone and Acetaminophen Tablets 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
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207419
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 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2106 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8834 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Proficient Rx LP | 71205-329 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Proficient Rx LP | 71205-347 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8888 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5169 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 2.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-320 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-321 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-322 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-323 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 2.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-113 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-114 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-115 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-116 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-193 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 2.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-191 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-192 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-950 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 2.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-948 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-949 |
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