Bimatoprost
- Product NDC
- 46708-507
- 11-digit product format
- 467080507
- Labeler code
- 46708
- Product ID
- 46708-507_f471cb1d-57c7-4556-99af-68f8c96059fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bimatoprost
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA210263
- Marketing category
- ANDA
- Marketing start
- 2019-04-12
- Substance
- BIMATOPROST
- Active strength
- .3 mg/mL
- Pharmacologic classes
- Prostaglandin Analog [EPC], Prostaglandins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bimatoprost
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BIMATOPROST | .3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QXS94885MZ |
| Rxcui | 308739 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-507-05 | Bimatoprost | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
| 46708-507-05 | Bimatoprost | 5.0 mL in 1 BOTTLE | SOLUTION/ DROPS | 5.0 | | 1 |
| 46708-507-25 | Bimatoprost | 2.5 mL in 1 BOTTLE | SOLUTION/ DROPS | 2.5 | | 1 |
| 46708-507-25 | Bimatoprost | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-507 | BIMATOPROST SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 4 package rows | 20230829_f471cb1d-57c7-4556-99af-68f8c96059fd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-507-05 | 46708050705 | 1 BOTTLE in 1 CARTON (46708-507-05) / 5 mL in 1 BOTTLE | 1 bottle | 2019-04-12 | No | No | Current |
| 46708-507-25 | 46708050725 | 1 BOTTLE in 1 CARTON (46708-507-25) / 2.5 mL in 1 BOTTLE | 1 bottle | 2019-04-12 | No | No | Current |