Tenofovir Disoproxil Fumarate
- Product NDC
- 42385-901
- 11-digit product format
- 423850901
- Labeler code
- 42385
- Product ID
- 42385-901_758c6876-348f-4c8a-a814-e811621ebd18
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tenofovir Disoproxil Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Laurus Labs Limited
- Application
- ANDA209550
- Marketing category
- ANDA
- Marketing start
- 2018-02-26
- Marketing end
- 0000-00-00
- Substance
- TENOFOVIR DISOPROXIL FUMARATE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42385-901-03 | Tenofovir Disoproxil Fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 42385-901-50 | Tenofovir Disoproxil Fumarate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42385-901 | TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [LAURUS LABS LIMITED] | 1 | Legacy NDC, 2 package rows | 20180228_758c6876-348f-4c8a-a814-e811621ebd18.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 42385-901-03 | 42385090103 | 30 in 1 BOTTLE | Historical |
| 42385-901-50 | 42385090150 | 500 in 1 BOTTLE | Historical |