Bromocriptine Mesylate

Product NDC
60687-286
11-digit product format
606870286
Labeler code
60687
Product ID
60687-286_e6ee3991-c759-085a-e053-2995a90a7a3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bromocriptine Mesylate
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA074631
Marketing category
ANDA
Marketing start
2017-07-07
Marketing end
0000-00-00
Substance
BROMOCRIPTINE MESYLATE
Active strength
3 mg/1
Pharmacologic classes
Ergolines [CS], Ergot Derivative [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60687-286DDiscontinued by firm2026-08-07
excluded packagepackage60687-28660687-286-21DDiscontinued by firm2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 22 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60687-286-21d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60687-286-21f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60687-286-212ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60687-286-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60687-286-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60687-286-21cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60687-286-21302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60687-286-21ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60687-286-210efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60687-286-21ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60687-286-21367a005e9d99…383a685ebd0f…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074631-001BROMOCRIPTINE MESYLATEBROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A074631-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-133f01610625f2…
2019-09-15 20:21 UTC2019-09A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074631-001BROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALAB1998-01-13cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074631-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074631-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074631-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074631-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074631-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074631-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074631-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074631-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074631-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074631-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074631-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074631-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074631-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074631-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074631-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074631-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074631-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074631-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074631-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074631-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074631-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074631-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074631-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074631-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074631-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074631-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074631-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074631-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074631-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074631-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074631-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074631-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074631-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074631-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074631-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074631-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074631-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074631-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074631-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074631-001AB1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-286-11EA - Each60687-286868c8707-c842-4b0a-b912-7e03c750b5d712017-08-11
60687-286-21EA - Each60687-286418e035b-6824-47a6-85d5-10d82213d17712017-08-11

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bromocriptine mesylateBROMOCRIPTINE MESYLATESandoz Incc43c300d-8aec-4020-984a-42c1a917c08f2024-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074631
application number: ANDA074631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-286-216068702862130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-286-21) > 1 TABLET in 1 BLISTER PACK (60687-286-11) 30 blister pack2017-07-070000-00-00NoNoCurrent