Home NDC 70512-860 Cabergoline
Product NDC 70512-860
11-digit product format 705120860
Labeler code 70512
Product ID 70512-860_45723c3c-bc96-6df6-e063-6294a90a8e1f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cabergoline
Dosage form TABLET
Route ORAL
Labeler SOLA Pharmaceuticals, LLC
Application ANDA076310
Marketing category ANDA
Marketing start 2023-05-08
Substance CABERGOLINE
Active strength .5 mg/1
Pharmacologic classes Ergolines [CS], Ergot Derivative [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 A076310-001 CABERGOLINE CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076310-001 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.
Product history page 1 of 2 · 41 observed 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 2026-02-19 14:30 UTC 2026-02 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL 2005-12-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB RS 2005-12-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL 2005-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL 2005-12-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL 2005-12-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL 2005-12-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL 2005-12-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB RS 2005-12-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB RS 2005-12-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB RS 2005-12-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB RS 2005-12-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076310-001 CABERGOLINE 0.5MG TABLET / ORAL AB 2005-12-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Cabergoline
Listing expiration 2026-12-31 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199703 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70512-860-08 Cabergoline 8 in 1 BOTTLE TABLET 8 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70512-860 CABERGOLINE TABLET [SOLA PHARMACEUTICALS, LLC] 3 Current NDC, 1 package rows 20240522_275a6a25-c3c9-4258-a610-0b00752517f7.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70512-860-08 70512086008 8 TABLET in 1 BOTTLE (70512-860-08) 8 tablet 2023-05-08 No No Current