Home NDC 0378-7096 Bromocriptine Mesylate
Product NDC 0378-7096
11-digit product format 003787096
Labeler code 0378
Product ID 0378-7096_caaa8c54-ee5c-47a9-8455-1f49fab45143
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bromocriptine mesylate
Dosage form CAPSULE
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA077226
Marketing category ANDA
Marketing start 2013-06-17
Marketing end 2027-04-30
Substance BROMOCRIPTINE MESYLATE
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 A077226-001 BROMOCRIPTINE MESYLATE BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077226-001 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 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077226-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB RS 2005-04-04 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 Active Ingredients# Ingredient, Strength table Ingredient Strength BROMOCRIPTINE MESYLATE 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 197412 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 0378-7096-01 Bromocriptine Mesylate 100 in 1 BOTTLE, UNIT-DOSE CAPSULE 100 11 0378-7096-93 Bromocriptine Mesylate 30 in 1 BOTTLE, UNIT-DOSE CAPSULE 30 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-7096 BROMOCRIPTINE MESYLATE CAPSULE [MYLAN PHARMACEUTICALS INC.] 11 Current NDC, Legacy NDC, 2 package rows 20211117_72d8eefe-c066-41b6-8922-9586f1cf47a1.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 · 1 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 0378-7096-01 00378709601 100 CAPSULE in 1 BOTTLE, UNIT-DOSE (0378-7096-01) 100 capsule 2013-07-01 0000-00-00 No No Current 0378-7096-93 00378709693 30 CAPSULE in 1 BOTTLE, UNIT-DOSE (0378-7096-93) 30 capsule 2013-06-17 0000-00-00 No No Current