Tenofovir Disoproxil Fumarate
- Product NDC
- 31722-535
- 11-digit product format
- 317220535
- Labeler code
- 31722
- Product ID
- 31722-535_f3388e9a-2c01-de8d-e053-2a95a90aa213
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tenofovir Disoproxil Fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA090636
- Marketing category
- ANDA
- Marketing start
- 2018-01-26
- 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 |
|---|
| 31722-535-01 | Tenofovir Disoproxil Fumarate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 4 |
| 31722-535-05 | Tenofovir Disoproxil Fumarate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 4 |
| 31722-535-10 | Tenofovir Disoproxil Fumarate | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 4 |
| 31722-535-30 | Tenofovir Disoproxil Fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 31722-535-60 | Tenofovir Disoproxil Fumarate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-535 | TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 5 package rows | 20230129_1ac4c628-f01f-42d4-b8e6-d12273aefc6d.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 |
|---|
| 31722-535-01 | 31722053501 | 100 TABLET, FILM COATED in 1 BOTTLE (31722-535-01) | 2018-01-26 | 0000-00-00 | No | No | Current |
| 31722-535-05 | 31722053505 | 500 TABLET, FILM COATED in 1 BOTTLE (31722-535-05) | 2018-01-26 | 0000-00-00 | No | No | Current |
| 31722-535-10 | 31722053510 | 1000 TABLET, FILM COATED in 1 BOTTLE (31722-535-10) | 2018-01-26 | 0000-00-00 | No | No | Current |
| 31722-535-30 | 31722053530 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-535-30) | 2018-01-26 | 0000-00-00 | No | No | Current |
| 31722-535-60 | 31722053560 | 60 TABLET, FILM COATED in 1 BOTTLE (31722-535-60) | 2018-01-26 | 0000-00-00 | No | No | Current |