Prescription drug · ANDA
Abacavir NDC 67046-1602
Abacavir sulfate 300 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1602-3 | 6704616020367046160203 | 30 TABLET in 1 BLISTER PACK (67046-1602-3)Marketed from Apr 1, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Route
- Oral
- Labeler
- Coupler LLCNDC labeler code 67046
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091560
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A1 Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
- Identifiers
- Product ID 67046-1602_48c0d443-a111-0039-e063-6394a90a9076SPL ID 48c0d443-a111-0039-e063-6394a90a9076SPL set ID 42ca758a-1694-c614-e063-6294a90a8c7eRxCUI 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
N467046160203followed by a unit qualifier and the quantityPackage 67046-1602-03. 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)
Abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, is 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 67046-1602
- What is NDC 67046-1602?
- 67046-1602 is the product NDC for Abacavir, Abacavir sulfate 300 mg/1 tablet, listed with the FDA by Coupler LLC. It has 1 package NDC, 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?
- Coupler LLC, NDC labeler code 67046. 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?
- 9 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 | 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 | Major Pharmaceuticals | 0904-6874 | 00904-6874-0400904-6874-06 |
Other NDCs under ANDA 091560
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 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-557 |
| Abacavir | Abacavir sulfate 300 mg/1 | TabletOral | XLCare Pharmaceuticals Inc. | 72865-167 |
| Abacavir | Abacavir sulfate 300 mg/1 | TabletOral | AvPAK | 50268-049 |