BROMOCRIPTINE MESYLATE

Product NDC
63304-962
Requested package NDC
63304-962-30
11-digit product format
633040962
Labeler code
63304
Product ID
63304-962_cf0b0c2b-20a7-4142-8648-27bc3894cf73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bromocriptine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA017962
Marketing category
NDA
Marketing start
2016-12-22
Marketing end
0000-00-00
Substance
BROMOCRIPTINE MESYLATE
Active strength
3 mg/1
Pharmacologic classes
Ergot Derivative [EPC],Ergolines [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63304-96263304-962-30IInactivated by FDA2026-08-03

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017962-001PARLODELBROMOCRIPTINE MESYLATEEQ 2.5MG BASETABLET / ORALABRLD, Approved before 1982
N017962-002PARLODELBROMOCRIPTINE MESYLATEEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD1982-03-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N017962-001AB
N017962-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N017962-001PARLODELEQ 2.5MG BASETABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017962-002PARLODELEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD1982-03-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017962-001PARLODELEQ 2.5MG BASETABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017962-002PARLODELEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD1982-03-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017962-001PARLODELEQ 2.5MG BASETABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017962-002PARLODELEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD1982-03-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017962-001PARLODELEQ 2.5MG BASETABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017962-002PARLODELEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD1982-03-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017962-001PARLODELEQ 2.5MG BASETABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017962-002PARLODELEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD1982-03-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017962-001PARLODELEQ 2.5MG BASETABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017962-002PARLODELEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD1982-03-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017962-001PARLODELEQ 2.5MG BASETABLET / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017962-002PARLODELEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD1982-03-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017962-001PARLODELEQ 2.5MG BASETABLET / ORALABRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017962-002PARLODELEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD1982-03-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017962-001PARLODELEQ 2.5MG BASETABLET / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017962-002PARLODELEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD1982-03-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017962-001PARLODELEQ 2.5MG BASETABLET / ORALABRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N017962-002PARLODELEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD1982-03-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017962-001PARLODELEQ 2.5MG BASETABLET / ORALABRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017962-002PARLODELEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD1982-03-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017962-001PARLODELEQ 2.5MG BASETABLET / ORALABRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017962-002PARLODELEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD1982-03-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017962-001PARLODELEQ 2.5MG BASETABLET / ORALABRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017962-002PARLODELEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD1982-03-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017962-001PARLODELEQ 2.5MG BASETABLET / ORALABRLD, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N017962-002PARLODELEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD1982-03-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017962-001PARLODELEQ 2.5MG BASETABLET / ORALABRLD, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017962-002PARLODELEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD1982-03-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017962-001PARLODELEQ 2.5MG BASETABLET / ORALABRLD, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N017962-002PARLODELEQ 5MG BASECAPSULE / ORALABRLD1982-03-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017962-001PARLODELEQ 2.5MG BASETABLET / ORALABRLD, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N017962-002PARLODELEQ 5MG BASECAPSULE / ORALABRLD1982-03-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017962-001PARLODELEQ 2.5MG BASETABLET / ORALABRLD, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N017962-002PARLODELEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**CAPSULE / ORALABRLD1982-03-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017962-001PARLODELEQ 2.5MG BASETABLET / ORALABRLD, Approved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N017962-002PARLODELEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD1982-03-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017962-001PARLODELEQ 2.5MG BASETABLET / ORALABRLD, Approved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N017962-002PARLODELEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**CAPSULE / ORALABRLD1982-03-01782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N017962-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017962-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017962-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017962-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017962-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017962-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017962-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017962-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017962-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017962-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017962-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017962-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017962-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017962-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017962-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017962-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017962-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017962-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017962-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N017962-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017962-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017962-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017962-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017962-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017962-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017962-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017962-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N017962-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017962-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017962-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017962-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N017962-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017962-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N017962-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017962-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N017962-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017962-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N017962-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017962-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N017962-002AB1782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
90f4f2b3-d032-9eaf-93c5-f165b5a4c90eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-962-01BROMOCRIPTINE MESYLATE100 in 1 BOTTLETABLET1004
63304-962-30BROMOCRIPTINE MESYLATE30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-962-01EA - Each63304-962cdf797ac-8b79-4c1d-844b-005d7f09dbec12017-03-06
63304-962-30EA - Each63304-962137ae8c4-d720-4bbe-85f8-15296741ada012017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-962BROMOCRIPTINE MESYLATE TABLET BROMOCRIPTINE MESYLATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]4Legacy NDC, 2 package rows20200212_44cc1e5f-c509-40e6-ac51-eba6d0440b16.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bromocriptine MesylateBROMOCRIPTINE MESYLATEANI Pharmaceuticals, Inc.17f3a343-1782-4799-95ba-31dfe93be2cf2026-07-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 017962
application number: NDA017962
Bromocriptine MesylateBROMOCRIPTINE MESYLATEAmerican Health Packagingddd292a5-72af-448f-8b88-cc4fd99ec7832026-06-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 017962
application number: NDA017962

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197411bromocriptine mesylate 2.5 MG Oral TabletPSN44cc1e5f-c509-40e6-ac51-eba6d0440b164
197412bromocriptine mesylate 5 MG Oral CapsulePSN44cc1e5f-c509-40e6-ac51-eba6d0440b164
197411bromocriptine 2.5 MG Oral TabletSCD44cc1e5f-c509-40e6-ac51-eba6d0440b164
197412bromocriptine 5 MG Oral CapsuleSCD44cc1e5f-c509-40e6-ac51-eba6d0440b164
197411bromocriptine (as bromocriptine mesylate) 2.5 MG Oral TabletSY44cc1e5f-c509-40e6-ac51-eba6d0440b164
197412bromocriptine 5 MG (as bromocriptine mesylate 5.74 MG) Oral CapsuleSY44cc1e5f-c509-40e6-ac51-eba6d0440b164

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63304-962-306330409623030 TABLET in 1 BOTTLE (63304-962-30) 30 tablet2016-12-220000-00-00NoNoCurrent