Prescription drug · ANDA
Oxycodone And Acetaminophen NDC 0904-7094
Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7094-61 | 0090470946100904709461 | 100 BLISTER PACK in 1 CARTON (0904-7094-61) / 1 TABLET in 1 BLISTER PACKMarketed from Jun 1, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 7.5 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207510
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0904-7094_b079798a-40f1-41e8-838f-e03ccdeb27feSPL ID b079798a-40f1-41e8-838f-e03ccdeb27feSPL set ID 1d52272f-a607-4002-a61c-341964522b82RxCUI 1049214, 1049221, 1049225UNII 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
N400904709461followed by a unit qualifier and the quantityPackage 00904-7094-61. 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the 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.
About NDC 0904-7094
- What is NDC 0904-7094?
- 0904-7094 is the product NDC for Oxycodone And Acetaminophen, Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oxycodone And Acetaminophen.
- What is the active ingredient?
- Oxycodone hydrochloride, Acetaminophen.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Oxycodone And Acetaminophen?
- 110 other product NDCs are listed under this name. See all Oxycodone And Acetaminophen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Oxycodone And Acetaminophen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-898 | 60760-0898-3060760-0898-60 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-899 | 60760-0899-3060760-0899-6060760-0899-90 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-897 | 60760-0897-3060760-0897-60 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Direct_Rx | 72189-368 | 72189-0368-3072189-0368-6072189-0368-72+1 more |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | American Health Packaging | 60687-642 | 60687-0642-01 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-668 | 70010-0668-0170010-0668-05 |
| Oxycodone and Acetaminophen | Acetaminophen 325 mg/1; Oxycodone hydrochloride 2.5 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-667 | 70010-0667-0170010-0667-05 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-669 | 70010-0669-0170010-0669-05 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-670 | 70010-0670-0170010-0670-05 |
| Oxycodone And Acetaminophen | Acetaminophen 325 mg/1; Oxycodone hydrochloride 7.5 mg/1 | TabletOral | DIRECT RX | 72189-256 | 72189-0256-3072189-0256-6072189-0256-72 |
Other NDCs under ANDA 207510
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 | Acetaminophen 325 mg/1; Oxycodone hydrochloride 7.5 mg/1 | TabletOral | DIRECT RX | 72189-256 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | DIRECT RX | 72189-255 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Asclemed USA, Inc. | 87063-033 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Asclemed USA, Inc. | 87063-032 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Asclemed USA, Inc. | 87063-034 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9675 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9674 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7093 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2049 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7095 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Eywa Pharma Inc | 71930-045 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Eywa Pharma Inc | 71930-046 |
| Oxycodone And Acetaminophen | Oxycodone hydrochloride 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Eywa Pharma Inc | 71930-047 |
| Oxycodone and Acetaminophen | Oxycodone hydrochloride 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | American Health Packaging | 60687-642 |