Tenofovir Disoproxil Fumarate
- Product NDC
- 71921-105
- 11-digit product format
- 719210105
- Labeler code
- 71921
- Product ID
- 71921-105_79278443-b9ee-4db6-ac15-a3d12b359eb0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tenofovir Disoproxil Fumarate
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Florida Pharmaceutical Products, LLC.
- Application
- ANDA209498
- Marketing category
- ANDA
- Marketing start
- 2025-11-26
- Substance
- TENOFOVIR DISOPROXIL FUMARATE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], 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
- Tenofovir Disoproxil Fumarate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TENOFOVIR DISOPROXIL FUMARATE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OTT9J7900I |
| Rxcui | 349251 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71921-105-33 | Tenofovir Disoproxil Fumarate | 30 in 1 BOTTLE, PLASTIC | TABLET, COATED | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71921-105-33 | 71921010533 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (71921-105-33) | 2025-11-26 | No | No | Current |