Prescription drug · ANDA
ABACAVIR and LAMIVUDINE NDC 31722-838
Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1 · Tablet, Film coated · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-838-30 | 3172208383031722083830 | 1 BOTTLE in 1 CARTON (31722-838-30) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 16, 2025 |
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 and LAMIVUDINE
- Generic name (nonproprietary)
- abacavir and lamivudine
- Active ingredients
- Abacavir sulfate — 600 mg/1Lamivudine — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205412
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A1 Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)Nucleoside Reverse Transcriptase Inhibitors (Mechanism)
- Identifiers
- Product ID 31722-838_366cb4c4-0386-17b7-e063-6394a90a5fd1SPL ID 366cb4c4-0386-17b7-e063-6394a90a5fd1SPL set ID e8988924-c18c-4e91-ab79-2d84e72bfa0dRxCUI 602393UNII J220T4J9Q2, 2T8Q726O95UPC 0331722838306
- Pharmacologic class
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor; 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
N431722083830followed by a unit qualifier and the quantityPackage 31722-0838-30. 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 and lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Abacavir and lamivudine tablets, a combination of abacavir and lamivudine, both nucleoside analogue HIV-1 reverse transcriptase inhibitors, 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 31722-838
- What is NDC 31722-838?
- 31722-838 is the product NDC for ABACAVIR and LAMIVUDINE, Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1 tablet, film coated, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- ABACAVIR and LAMIVUDINE.
- What is the active ingredient?
- Abacavir sulfate, Lamivudine.
- Who is the labeler?
- Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 and LAMIVUDINE?
- 5 other product NDCs are listed under this name. See all ABACAVIR and LAMIVUDINE NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other ABACAVIR and LAMIVUDINE 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 and Lamivudine | Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-440 | 33342-0440-0733342-0440-1433342-0440-98 |
| Abacavir and Lamivudine | Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1 | Tablet, Film coatedOral | Laurus Labs Limited | 42385-962 | 42385-0962-1842385-0962-3042385-0962-90 |
| Abacavir and Lamivudine | Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-335 | 65862-0335-1065862-0335-30 |
| Abacavir and Lamivudine | Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-288 | — |
| Abacavir and Lamivudine | Abacavir sulfate 600 mg/1; Lamivudine 300 mg/1 | Tablet, Film coatedOral | Cipla USA Inc. | 69097-362 | 69097-0362-02 |