Emtricitabine and Tenofovir Disoproxil Fumarate
- Product NDC
- 68071-3986
- 11-digit product format
- 680713986
- Labeler code
- 68071
- Product ID
- 68071-3986_4feb8fee-d56c-157c-e063-6394a90a6468
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Emtricitabine and Tenofovir Disoproxil Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- 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
- 2027-12-31
- 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 |
|---|
| 68071-3986-3 | Emtricitabine and Tenofovir Disoproxil Fumarate | 3 in 1 BOTTLE | TABLET, FILM COATED | 3 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3986-3 | 68071398603 | 3 TABLET, FILM COATED in 1 BOTTLE (68071-3986-3) | 2026-04-20 | No | No | Historical |