bromocriptine mesylate

Generic: bromocriptine mesylate

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name bromocriptine mesylate
Generic Name bromocriptine mesylate
Labeler ani pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

bromocriptine mesylate 2.5 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-978
Product ID 70954-978_17f3a343-1782-4799-95ba-31dfe93be2cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017962
Listing Expiration 2026-12-31
Marketing Start 2025-06-15

Pharmacologic Class

Classes
ergolines [cs] ergot derivative [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954978
Hyphenated Format 70954-978

Supplemental Identifiers

RxCUI
197411
UPC
0370954978107 0370954978206
UNII
FFP983J3OD

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bromocriptine mesylate (source: ndc)
Generic Name bromocriptine mesylate (source: ndc)
Application Number NDA017962 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (70954-978-10)
  • 100 TABLET in 1 BOTTLE (70954-978-20)
source: ndc

Packages (2)

70954-978-10 30 TABLET in 1 BOTTLE (70954-978-10) 70954-978-20 100 TABLET in 1 BOTTLE (70954-978-20)

Ingredients (1)

bromocriptine mesylate (2.5 mg/1)

Linked Drug Pages (1)

Bromocriptine Mesylate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "17f3a343-1782-4799-95ba-31dfe93be2cf", "openfda": {"upc": ["0370954978107", "0370954978206"], "unii": ["FFP983J3OD"], "rxcui": ["197411"], "spl_set_id": ["17f3a343-1782-4799-95ba-31dfe93be2cf"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (70954-978-10)", "package_ndc": "70954-978-10", "marketing_start_date": "20250615"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (70954-978-20)", "package_ndc": "70954-978-20", "marketing_start_date": "20250615"}], "brand_name": "Bromocriptine Mesylate", "product_id": "70954-978_17f3a343-1782-4799-95ba-31dfe93be2cf", "dosage_form": "TABLET", "pharm_class": ["Ergolines [CS]", "Ergot Derivative [EPC]"], "product_ndc": "70954-978", "generic_name": "Bromocriptine Mesylate", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bromocriptine Mesylate", "active_ingredients": [{"name": "BROMOCRIPTINE MESYLATE", "strength": "2.5 mg/1"}], "application_number": "NDA017962", "marketing_category": "NDA", "marketing_start_date": "20250615", "listing_expiration_date": "20261231"}