Emtricitabine and tenofovir disoproxil fumarate
- Product NDC
- 70710-1366
- 11-digit product format
- 707101366
- Labeler code
- 70710
- Product ID
- 70710-1366_919c0aaa-f6d2-426d-a673-ef5c806f9a3a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Emtricitabine and tenofovir disoproxil fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA212689
- Marketing category
- ANDA
- Marketing start
- 2021-07-01
- Substance
- EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
- Active strength
- 167; 250 mg/1; mg/1
- Pharmacologic classes
- 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], Nucleosides [CS], Nucleosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Emtricitabine and tenofovir disoproxil fumarate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EMTRICITABINE | 167 mg/1 |
| TENOFOVIR DISOPROXIL FUMARATE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G70B4ETF4S, OTT9J7900I |
| Rxcui | 476556, 1744001, 1744005, 1744009 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70710-1366-2 | Emtricitabine and tenofovir disoproxil fumarate | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 8 |
| 70710-1366-3 | Emtricitabine and tenofovir disoproxil fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 70710-1366-4 | Emtricitabine and tenofovir disoproxil fumarate | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 8 |
| 70710-1366-9 | Emtricitabine and tenofovir disoproxil fumarate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70710-1366 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] | 8 | Current NDC, Legacy NDC, 4 package rows | 20240518_7def7a95-e69e-4985-974a-efacadcecc95.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 |
|---|
| 70710-1366-2 | 70710136602 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 70710-1366-3 | 70710136603 | 30 TABLET, FILM COATED in 1 BOTTLE (70710-1366-3) | | 2021-07-01 | 0000-00-00 | No | No | Current |
| 70710-1366-4 | 70710136604 | 10 BLISTER PACK in 1 CARTON (70710-1366-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70710-1366-2) | 10 blister pack | 2021-07-01 | 0000-00-00 | No | No | Current |
| 70710-1366-9 | 70710136609 | 90 TABLET, FILM COATED in 1 BOTTLE (70710-1366-9) | | 2021-07-01 | 0000-00-00 | No | No | Current |