Emtricitabine and tenofovir disoproxil fumarate
- Product NDC
- 16714-534
- 11-digit product format
- 167140534
- Labeler code
- 16714
- Product ID
- 16714-534_1fab5d61-9784-4a57-9895-cb797fae1400
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Emtricitabine and tenofovir disoproxil fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NorthStar RxLLC
- Application
- ANDA203442
- Marketing category
- ANDA
- Marketing start
- 2022-03-09
- 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 |
|---|
| 16714-534-01 | Emtricitabine and tenofovir disoproxil fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-534 | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [NORTHSTAR RXLLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20220805_fbbc7b73-eddf-40b5-8ebb-7b3d9c42dba6.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 |
|---|
| 16714-534-01 | 16714053401 | 30 TABLET, FILM COATED in 1 BOTTLE (16714-534-01) | 2022-03-09 | 0000-00-00 | No | No | Current |