Abacavir and Lamivudine
- Product NDC
- 35573-402
- 11-digit product format
- 355730402
- Labeler code
- 35573
- Product ID
- 35573-402_d38238aa-e4c0-41b9-bb70-026c546850f3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Abacavir and Lamivudine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Burel Pharmaceuticals, LLC
- Application
- ANDA206151
- Marketing category
- ANDA
- Marketing start
- 2017-03-28
- Marketing end
- 2022-02-28
- Substance
- ABACAVIR SULFATE; LAMIVUDINE
- Active strength
- 600 mg/1; mg/1
- Pharmacologic classes
- Cytochrome P450 1A1 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 35573-402-30 | 35573040230 | 1 BOTTLE in 1 CARTON (35573-402-30) > 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2017-03-28 | 0000-00-00 | No | No | Current |