Atazanavir Sulfate
- Product NDC
- 65862-713
- 11-digit product format
- 658620713
- Labeler code
- 65862
- Product ID
- 65862-713_8f8c56e0-40ee-4643-88f7-d3571ff5a409
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atazanavir
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA204806
- Marketing category
- ANDA
- Marketing start
- 2018-06-25
- Substance
- ATAZANAVIR SULFATE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Atazanavir Sulfate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATAZANAVIR SULFATE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4MT4VIE29P |
| Rxcui | 402245, 402246, 402247, 664741 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-713-03 | Atazanavir Sulfate | 3 in 1 CARTON | CAPSULE | 3 | | 8 |
| 65862-713-05 | Atazanavir Sulfate | 500 in 1 BOTTLE | CAPSULE | 500 | | 8 |
| 65862-713-10 | Atazanavir Sulfate | 10 in 1 BLISTER PACK | CAPSULE | 10 | | 8 |
| 65862-713-30 | Atazanavir Sulfate | 30 in 1 BOTTLE | CAPSULE | 30 | | 8 |
| 65862-713-90 | Atazanavir Sulfate | 90 in 1 BOTTLE | CAPSULE | 90 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-713 | ATAZANAVIR SULFATE (ATAZANAVIR) CAPSULE [AUROBINDO PHARMA LIMITED] | 7 | Current NDC, Legacy NDC, 5 package rows | 20250206_7fbea274-d6b5-4faa-bbf0-05fefab42114.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65862-713-03 | 65862071303 | 3 BLISTER PACK in 1 CARTON (65862-713-03) / 10 CAPSULE in 1 BLISTER PACK (65862-713-10) | 3 blister pack | 2018-06-25 | 0000-00-00 | No | No | Current |
| 65862-713-05 | 65862071305 | 500 CAPSULE in 1 BOTTLE (65862-713-05) | 500 capsule | 2018-06-25 | 0000-00-00 | No | No | Current |
| 65862-713-10 | 65862071310 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 65862-713-30 | 65862071330 | 30 CAPSULE in 1 BOTTLE (65862-713-30) | 30 capsule | 2018-06-25 | 0000-00-00 | No | No | Current |
| 65862-713-90 | 65862071390 | 90 CAPSULE in 1 BOTTLE (65862-713-90) | 90 capsule | 2018-06-25 | 0000-00-00 | No | No | Current |