Home NDC 68382-110 Bromocriptine mesylate
Product NDC 68382-110
11-digit product format 683820110
Labeler code 68382
Product ID 68382-110_b9165827-6509-4d3c-813a-547929b720da
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bromocriptine mesylate
Dosage form CAPSULE
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA078899
Marketing category ANDA
Marketing start 2009-01-23
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 A078899-001 BROMOCRIPTINE MESYLATE BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078899-001 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 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078899-001 BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE / ORAL AB 2008-07-30 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 2027-12-31 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 68382-110-01 Bromocriptine mesylate 100 in 1 BOTTLE CAPSULE 100 13 68382-110-06 Bromocriptine mesylate 30 in 1 BOTTLE CAPSULE 30 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-110 BROMOCRIPTINE MESYLATE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.] 13 Current NDC, Legacy NDC, 2 package rows 20230917_d69003ee-0b6f-47a9-834e-ba59c02f566c.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 68382-110-01 68382011001 100 CAPSULE in 1 BOTTLE (68382-110-01) 100 capsule 2009-01-23 0000-00-00 No No Current 68382-110-06 68382011006 30 CAPSULE in 1 BOTTLE (68382-110-06) 30 capsule 2009-01-23 0000-00-00 No No Current