Bexarotene
- Product NDC
- 0378-6955
- 11-digit product format
- 003786955
- Labeler code
- 0378
- Product ID
- 0378-6955_43459ab6-17fd-4c77-b269-4a97780af170
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bexarotene
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA203174
- Marketing category
- ANDA
- Marketing start
- 2015-07-09
- Substance
- BEXAROTENE
- Active strength
- 75 mg/1
- Pharmacologic classes
- Retinoid [EPC], Retinoids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bexarotene
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BEXAROTENE | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A61RXM4375 |
| Rxcui | 308725 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-6955-01 | Bexarotene | 100 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 100 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BEXAROTENE | ACTIVE INGREDIENT | A61RXM4375 | BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| BEXAROTENE | ACTIVE MOIETY | A61RXM4375 | BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-6955 | BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20211218_2d1eb4bd-51f9-4c9b-9fb1-0be5e30a3dc5.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 |
|---|
| 0378-6955-01 | 00378695501 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0378-6955-01) | 2015-07-09 | 0000-00-00 | No | No | Current |