Tenofovir Disoproxil Fumarate
- Product NDC
- 65862-820
- 11-digit product format
- 658620820
- Labeler code
- 65862
- Product ID
- 65862-820_ab772f55-3f84-41df-a84f-3a7035602cfd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tenofovir Disoproxil Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA090647
- Marketing category
- ANDA
- Marketing start
- 2018-01-26
- Substance
- TENOFOVIR DISOPROXIL FUMARATE
- Active strength
- 250 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 | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OTT9J7900I |
| Rxcui | 349251, 1243227, 1243324, 1243328 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-820-03 | Tenofovir Disoproxil Fumarate | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 18 |
| 65862-820-03 | Tenofovir Disoproxil Fumarate | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 18 |
| 65862-820-30 | Tenofovir Disoproxil Fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-820 | TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 18 | Current NDC, Legacy NDC, 3 package rows | 20240608_a75c6be8-3719-4bb3-8a9e-06e5254d2a82.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 |
|---|
| 65862-820-03 | 65862082003 | 3 BLISTER PACK in 1 CARTON (65862-820-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 3 blister pack | 2018-01-26 | 0000-00-00 | No | No | Current |
| 65862-820-30 | 65862082030 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-820-30) | | 2018-01-26 | 0000-00-00 | No | No | Current |