bimatoprost
- Product NDC
- 46708-511
- 11-digit product format
- 467080511
- Labeler code
- 46708
- Product ID
- 46708-511_2b4107e4-c108-4ed5-b7e8-253b74f2ff25
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bimatoprost
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA210515
- Marketing category
- ANDA
- Marketing start
- 2023-07-21
- 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 |
|---|
| 46708-511-03 | bimatoprost | 3 mL in 1 BOTTLE | SOLUTION/ DROPS | 3 | | 1 |
| 46708-511-03 | bimatoprost | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
| 46708-511-05 | bimatoprost | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | | 1 |
| 46708-511-05 | 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 |
|---|
| 46708-511 | BIMATOPROST SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 4 package rows | 20230722_2b4107e4-c108-4ed5-b7e8-253b74f2ff25.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 |
|---|
| 46708-511-03 | 46708051103 | 1 BOTTLE in 1 CARTON (46708-511-03) / 3 mL in 1 BOTTLE | 1 bottle | 2023-07-21 | No | No | Current |
| 46708-511-05 | 46708051105 | 1 BOTTLE in 1 CARTON (46708-511-05) / 5 mL in 1 BOTTLE | 1 bottle | 2023-07-21 | No | No | Current |