Emtricitabine and Tenofovir Disoproxil Fumarate
- Product NDC
- 0904-7172
- 11-digit product format
- 009047172
- Labeler code
- 0904
- Product ID
- 0904-7172_e3e2c3b9-806a-4639-ab44-5c5b4bb1166e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Emtricitabine and Tenofovir Disoproxil Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA212114
- Marketing category
- ANDA
- Marketing start
- 2019-07-26
- 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
- 2027-12-31
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 |
|---|
| 0904-7172-07 | Emtricitabine and Tenofovir Disoproxil Fumarate | 30 in 1 CARTON | TABLET, FILM COATED | 30 | | 6 |
| 0904-7172-07 | Emtricitabine and Tenofovir Disoproxil Fumarate | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7172 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250206_a78b51c9-c944-4b00-af81-9ecbfbb29fd1.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 |
|---|
| 0904-7172-07 | 00904717207 | 30 BLISTER PACK in 1 CARTON (0904-7172-07) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 30 blister pack | 2019-07-26 | 0000-00-00 | No | No | Current |