Emtricitabine and Tenofovir Disoproxil Fumarate
- Product NDC
- 69238-2092
- 11-digit product format
- 692382092
- Labeler code
- 69238
- Product ID
- 69238-2092_e3f72707-b2b3-49e4-8b28-a9311e1358cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Emtricitabine and Tenofovir Disoproxil Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA209721
- Marketing category
- ANDA
- Marketing start
- 2018-08-26
- Substance
- EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
- Active strength
- 100; 150 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 | 100 mg/1 |
| TENOFOVIR DISOPROXIL FUMARATE | 150 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 |
|---|
| 69238-2092-3 | Emtricitabine and Tenofovir Disoproxil Fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-2092 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] | 9 | Current NDC, Legacy NDC, 1 package rows | 20231230_b0459301-2bff-4336-9172-b90c7a582433.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69238-2092-3 | 69238209203 | 30 TABLET, FILM COATED in 1 BOTTLE (69238-2092-3) | 2018-08-26 | 0000-00-00 | No | No | Current |