cabergoline

Generic: cabergoline

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cabergoline
Generic Name cabergoline
Labeler amneal pharmaceuticals ny llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cabergoline .5 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-2693
Product ID 69238-2693_3e2ff3e8-fa09-469e-b545-68ab6b168de7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218618
Listing Expiration 2026-12-31
Marketing Start 2024-10-03

Pharmacologic Class

Established (EPC)
ergot derivative [epc]
Chemical Structure
ergolines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692382693
Hyphenated Format 69238-2693

Supplemental Identifiers

RxCUI
199703
UPC
0369238269314
UNII
LL60K9J05T
NUI
M0007652 N0000175827

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 cabergoline (source: ndc)
Generic Name cabergoline (source: ndc)
Application Number ANDA218618 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 8 TABLET in 1 BOTTLE (69238-2693-1)
source: ndc

Packages (1)

69238-2693-1 8 TABLET in 1 BOTTLE (69238-2693-1)

Ingredients (1)

cabergoline (.5 mg/1)

Linked Drug Pages (1)

Cabergoline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3e2ff3e8-fa09-469e-b545-68ab6b168de7", "openfda": {"nui": ["M0007652", "N0000175827"], "upc": ["0369238269314"], "unii": ["LL60K9J05T"], "rxcui": ["199703"], "spl_set_id": ["a246b015-e19c-4b4f-9089-aea1108687ba"], "pharm_class_cs": ["Ergolines [CS]"], "pharm_class_epc": ["Ergot Derivative [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 TABLET in 1 BOTTLE (69238-2693-1)", "package_ndc": "69238-2693-1", "marketing_start_date": "20241003"}], "brand_name": "Cabergoline", "product_id": "69238-2693_3e2ff3e8-fa09-469e-b545-68ab6b168de7", "dosage_form": "TABLET", "pharm_class": ["Ergolines [CS]", "Ergot Derivative [EPC]"], "product_ndc": "69238-2693", "generic_name": "Cabergoline", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cabergoline", "active_ingredients": [{"name": "CABERGOLINE", "strength": ".5 mg/1"}], "application_number": "ANDA218618", "marketing_category": "ANDA", "marketing_start_date": "20241003", "listing_expiration_date": "20261231"}