Home NDC 0574-0106 Bromocriptine mesylate
Product NDC 0574-0106
11-digit product format 005740106
Labeler code 0574
Product ID 0574-0106_3a655bc4-d44e-4dd2-a951-211d8484f788
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bromocriptine mesylate
Dosage form TABLET
Route ORAL
Labeler Padagis US LLC
Application ANDA077646
Marketing category ANDA
Marketing start 2014-04-01
Substance BROMOCRIPTINE MESYLATE
Active strength 2.5 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 A077646-001 BROMOCRIPTINE MESYLATE BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077646-001 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 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077646-001 BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET / ORAL AB RS 2008-10-01 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Bromocriptine mesylate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BROMOCRIPTINE MESYLATE 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FFP983J3OD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197411 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 0574-0106-01 Bromocriptine mesylate 100 in 1 BOTTLE, PLASTIC TABLET 100 10 0574-0106-03 Bromocriptine mesylate 30 in 1 BOTTLE, PLASTIC TABLET 30 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0574-0106 BROMOCRIPTINE MESYLATE TABLET [PADAGIS US LLC] 10 Current NDC, Legacy NDC, 2 package rows 20241123_0ee2da00-faf8-4c51-a696-9462fa4f6050.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0574-0106-01 00574010601 100 TABLET in 1 BOTTLE, PLASTIC (0574-0106-01) 100 tablet 2014-04-01 0000-00-00 No No Current 0574-0106-03 00574010603 30 TABLET in 1 BOTTLE, PLASTIC (0574-0106-03) 30 tablet 2014-04-01 0000-00-00 No No Current