bromocriptine mesylate

Generic: bromocriptine mesylate

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bromocriptine mesylate
Generic Name bromocriptine mesylate
Labeler zydus pharmaceuticals usa inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

bromocriptine mesylate 5 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-110
Product ID 68382-110_b9165827-6509-4d3c-813a-547929b720da
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078899
Listing Expiration 2026-12-31
Marketing Start 2009-01-23

Pharmacologic Class

Classes
ergolines [cs] ergot derivative [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382110
Hyphenated Format 68382-110

Supplemental Identifiers

RxCUI
197412
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 ANDA078899 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (68382-110-01)
  • 30 CAPSULE in 1 BOTTLE (68382-110-06)
source: ndc

Packages (2)

68382-110-01 100 CAPSULE in 1 BOTTLE (68382-110-01) 68382-110-06 30 CAPSULE in 1 BOTTLE (68382-110-06)

Ingredients (1)

bromocriptine mesylate (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": "b9165827-6509-4d3c-813a-547929b720da", "openfda": {"unii": ["FFP983J3OD"], "rxcui": ["197412"], "spl_set_id": ["d69003ee-0b6f-47a9-834e-ba59c02f566c"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68382-110-01)", "package_ndc": "68382-110-01", "marketing_start_date": "20090123"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68382-110-06)", "package_ndc": "68382-110-06", "marketing_start_date": "20090123"}], "brand_name": "Bromocriptine mesylate", "product_id": "68382-110_b9165827-6509-4d3c-813a-547929b720da", "dosage_form": "CAPSULE", "pharm_class": ["Ergolines [CS]", "Ergot Derivative [EPC]"], "product_ndc": "68382-110", "generic_name": "Bromocriptine mesylate", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bromocriptine mesylate", "active_ingredients": [{"name": "BROMOCRIPTINE MESYLATE", "strength": "5 mg/1"}], "application_number": "ANDA078899", "marketing_category": "ANDA", "marketing_start_date": "20090123", "listing_expiration_date": "20261231"}