Prescription drug · ANDA
Abacavir (Abacavir sulfate) NDC 65862-089
Abacavir sulfate 20 mg/mL · Solution · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-089-24 | 65862008924 | 1 BOTTLE in 1 CARTON (65862-089-24) / 240 mL in 1 BOTTLEMarketed from Mar 14, 2018 |
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)
- Abacavir
- Generic name (nonproprietary)
- abacavir sulfate
- Active ingredients
- Abacavir sulfate — 20 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077950
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A1 Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
- Identifiers
- Product ID 65862-089_e1bbcda5-e1ce-48d6-99d0-8545112b08c8SPL ID e1bbcda5-e1ce-48d6-99d0-8545112b08c8SPL set ID e2214976-657c-4018-b059-1ad66a7e2b6fRxCUI 242680UNII J220T4J9Q2UPC 0365862089243
- 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
N465862008924followed by a unit qualifier and the quantityPackage 65862-0089-24. 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 oral solution, in combination with other antiretroviral agents, is 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 65862-089
- What is NDC 65862-089?
- 65862-089 is the product NDC for Abacavir (abacavir sulfate), Abacavir sulfate 20 mg/mL solution, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Abacavir (Abacavir Sulfate).
- What is the active ingredient?
- Abacavir sulfate.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. 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 |
| 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 |
| Abacavir | Abacavir sulfate 300 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-073 | 65862-0073-60 |
Other NDCs under ANDA 077950
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 |
|---|---|---|---|---|
| Abacavirabacavir sulfate | Abacavir sulfate 20 mg/mL | SolutionOral | Rising Pharma Holdings, Inc. | 64980-405 |