Emtricitabine and tenofovir disoproxil fumarate
- Product NDC
- 70771-1621
- 11-digit product format
- 707711621
- Labeler code
- 70771
- Product ID
- 70771-1621_8fb1b15c-e324-4410-9a1b-2b3a2ffee3f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Emtricitabine and tenofovir disoproxil fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA212689
- Marketing category
- ANDA
- Marketing start
- 2021-07-01
- Substance
- EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
- Active strength
- 133; 200 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 | 133 mg/1 |
| TENOFOVIR DISOPROXIL FUMARATE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OTT9J7900I, G70B4ETF4S |
| 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 |
|---|
| 70771-1621-2 | Emtricitabine and tenofovir disoproxil fumarate | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 6 |
| 70771-1621-3 | Emtricitabine and tenofovir disoproxil fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
| 70771-1621-4 | Emtricitabine and tenofovir disoproxil fumarate | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 6 |
| 70771-1621-9 | Emtricitabine and tenofovir disoproxil fumarate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1621 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] | 6 | Current NDC, Legacy NDC, 4 package rows | 20241201_a0ee89b6-72c3-4b99-8d1c-d7473f1d5ef3.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 |
|---|
| 70771-1621-2 | 70771162102 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 70771-1621-3 | 70771162103 | 30 TABLET, FILM COATED in 1 BOTTLE (70771-1621-3) | | 2021-07-01 | 0000-00-00 | No | No | Current |
| 70771-1621-4 | 70771162104 | 10 BLISTER PACK in 1 CARTON (70771-1621-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1621-2) | 10 blister pack | 2021-07-01 | 0000-00-00 | No | No | Current |
| 70771-1621-9 | 70771162109 | 90 TABLET, FILM COATED in 1 BOTTLE (70771-1621-9) | | 2021-07-01 | 0000-00-00 | No | No | Current |