Emtricitabine and Tenofovir Disoproxil Fumarate
- Product NDC
- 42543-719
- 11-digit product format
- 425430719
- Labeler code
- 42543
- Product ID
- 42543-719_427e3960-fb3a-429d-8651-b62e7b97479d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- EMTRICITABINE and TENOFOVIR Disoproxil Fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Strides Pharma Inc.
- Application
- ANDA091055
- Marketing category
- ANDA
- Marketing start
- 2021-03-30
- Substance
- EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
- Active strength
- 200; 300 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 | 200 mg/1 |
| TENOFOVIR DISOPROXIL FUMARATE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G70B4ETF4S, OTT9J7900I |
| Rxcui | 476556 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42543-719-04 | Emtricitabine and Tenofovir Disoproxil Fumarate | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42543-719 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET [STRIDES PHARMA INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240321_7ecc604c-c4b4-4419-a733-ecb11662fc81.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 |
|---|
| 42543-719-04 | 42543071904 | 30 TABLET in 1 BOTTLE, PLASTIC (42543-719-04) | 30 tablet | 2021-03-30 | 0000-00-00 | No | No | Current |