EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
- Product NDC
- 69097-741
- 11-digit product format
- 690970741
- Labeler code
- 69097
- Product ID
- 69097-741_07c79c8d-b3e7-442b-8a53-ad5dc71f28a5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA090958
- Marketing category
- ANDA
- Marketing start
- 2021-11-01
- 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 |
|---|
| 69097-741-02 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-741 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [CIPLA USA INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20250104_d08c9455-e788-435c-9076-2bdb1a4f5b37.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 |
|---|
| 69097-741-02 | 69097074102 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-741-02) | 2021-11-01 | 0000-00-00 | No | No | Current |