Home NDC 27808-315-01 CABERGOLINE
Product NDC 27808-315
Requested package NDC 27808-315-01
11-digit product format 278080315
Labeler code 27808
Product ID 27808-315_54d6bd6b-a5af-68e4-e063-6394a90a58a0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CABERGOLINE
Dosage form TABLET
Route ORAL
Labeler Cranbury Pharmaceuticals, LLC
Application ANDA220309
Marketing category ANDA
Marketing start 2026-08-01
Substance CABERGOLINE
Active strength .5 mg/1
Pharmacologic classes Ergolines [CS]; Ergot Derivative [EPC]
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220309-001 CABERGOLINE CABERGOLINE 0.5MG TABLET / ORAL AB 2026-06-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220309-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220309-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2026-06-15 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220309-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base CABERGOLINE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CABERGOLINE .5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LL60K9J05T Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 27808-315-01 27808031501 8 TABLET in 1 BOTTLE (27808-315-01) 8 tablet 2026-08-01 0 Current