Prescription drug · ANDA
Abacavir NDC 0904-6874
Abacavir sulfate 300 mg/1 · Tablet, Film coated · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6874-04 | 00904687404 | 30 BLISTER PACK in 1 CARTON (0904-6874-04) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Dec 17, 2012 | |
| 0904-6874-06 | 00904687406 | 50 BLISTER PACK in 1 CARTON (0904-6874-06) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Dec 17, 2012 |
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)
- Abacavir
- Generic name (nonproprietary)
- abacavir
- Active ingredients
- Abacavir sulfate — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077844
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A1 Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
- Identifiers
- Product ID 0904-6874_8a0bf056-72b0-4a2e-8eb8-988fbf101b5dSPL ID 8a0bf056-72b0-4a2e-8eb8-988fbf101b5dSPL set ID 4b286ec6-68a7-4ec0-af07-5a27ec9cb35dRxCUI 242679UNII J220T4J9Q2
- Pharmacologic class
- Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
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
N400904687404followed by a unit qualifier and the quantityPackage 00904-6874-04. 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)
Abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir tablets, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0904-6874
- What is NDC 0904-6874?
- 0904-6874 is the product NDC for Abacavir, Abacavir sulfate 300 mg/1 tablet, film coated, listed with the FDA by Major Pharmaceuticals. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Abacavir.
- What is the active ingredient?
- Abacavir sulfate.
- 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 Abacavir?
- 10 other product NDCs are listed under this name. See all Abacavir NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Abacavir products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Abacavir | Abacavir sulfate 300 mg/1 | TabletOral | XLCare Pharmaceuticals Inc. | 72865-167 | 72865-0167-60 |
| Abacavir | Abacavir sulfate 300 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-557 | 31722-0557-60 |
| Abacavir | Abacavir sulfate 300 mg/1 | TabletOral | Coupler LLC | 67046-1602 | 67046-1602-03 |
| Abacavir | Abacavir sulfate 300 mg/1 | TabletOral | AvPAK | 50268-049 | 50268-0049-12 |
| Abacavirabacavir sulfate | Abacavir sulfate 20 mg/mL | SolutionOral | Rising Pharma Holdings, Inc. | 64980-405 | 64980-0405-24 |
| Abacavirabacavir sulfate | Abacavir sulfate 20 mg/mL | SolutionOral | Aurobindo Pharma Limited | 65862-089 | 65862-0089-24 |
| Abacavir | Abacavir sulfate 300 mg/1 | Tablet, Film coatedOral | Cipla USA Inc. | 69097-514 | 69097-0514-03 |
| Abacavir | Abacavir sulfate 20 mg/mL | SolutionOral | Camber Pharmaceuticals, Inc. | 31722-562 | 31722-0562-24 |
| Abacavir | Abacavir sulfate 300 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-021 | 68084-0021-21 |
| Abacavir | Abacavir sulfate 300 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-073 | 65862-0073-60 |
Other NDCs under ANDA 077844
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 |
|---|---|---|---|---|
| Abacavir | Abacavir sulfate 300 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-073 |
| Abacavir | Abacavir sulfate 300 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-021 |