cabergoline

Generic: cabergoline

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cabergoline
Generic Name cabergoline
Labeler somerset therapeutics, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cabergoline .5 mg/1

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-824
Product ID 70069-824_999ea838-e592-4769-a702-68d934de3e1d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218109
Listing Expiration 2026-12-31
Marketing Start 2024-10-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069824
Hyphenated Format 70069-824

Supplemental Identifiers

RxCUI
199703
UPC
0370069824085
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 ANDA218109 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 8 TABLET in 1 BOTTLE (70069-824-08)
source: ndc

Packages (1)

70069-824-08 8 TABLET in 1 BOTTLE (70069-824-08)

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": "999ea838-e592-4769-a702-68d934de3e1d", "openfda": {"nui": ["M0007652", "N0000175827"], "upc": ["0370069824085"], "unii": ["LL60K9J05T"], "rxcui": ["199703"], "spl_set_id": ["e0fb5556-de2c-4822-9960-0700e2907890"], "pharm_class_cs": ["Ergolines [CS]"], "pharm_class_epc": ["Ergot Derivative [EPC]"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 TABLET in 1 BOTTLE (70069-824-08)", "package_ndc": "70069-824-08", "marketing_start_date": "20241018"}], "brand_name": "CABERGOLINE", "product_id": "70069-824_999ea838-e592-4769-a702-68d934de3e1d", "dosage_form": "TABLET", "pharm_class": ["Ergolines [CS]", "Ergot Derivative [EPC]"], "product_ndc": "70069-824", "generic_name": "CABERGOLINE", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CABERGOLINE", "active_ingredients": [{"name": "CABERGOLINE", "strength": ".5 mg/1"}], "application_number": "ANDA218109", "marketing_category": "ANDA", "marketing_start_date": "20241018", "listing_expiration_date": "20261231"}