Bromocriptine Mesylate
- Product NDC
- 70954-978
- 11-digit product format
- 709540978
- Labeler code
- 70954
- Product ID
- 70954-978_45243870-6592-4cdf-a2a1-2e8ea48a47d8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bromocriptine Mesylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- NDA017962
- Marketing category
- NDA
- Marketing start
- 2025-06-15
- Substance
- BROMOCRIPTINE MESYLATE
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Ergolines [CS], Ergot Derivative [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bromocriptine Mesylate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BROMOCRIPTINE MESYLATE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FFP983J3OD |
| Rxcui | 197411, 197412 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70954-978-10 | Bromocriptine Mesylate | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 70954-978-20 | Bromocriptine Mesylate | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70954-978-10 | 70954097810 | 30 TABLET in 1 BOTTLE (70954-978-10) | 30 tablet | 2025-06-15 | No | No | Current |
| 70954-978-20 | 70954097820 | 100 TABLET in 1 BOTTLE (70954-978-20) | 100 tablet | 2025-06-15 | No | No | Current |