FDA.reportPublic FDA data

Bromocriptine Mesylate

Product NDC
70954-951
11-digit product format
709540951
Labeler code
70954
Product ID
70954-951_45243870-6592-4cdf-a2a1-2e8ea48a47d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bromocriptine Mesylate
Dosage form
CAPSULE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
NDA017962
Marketing category
NDA
Marketing start
2026-04-06
Substance
BROMOCRIPTINE MESYLATE
Active strength
5 mg/1
Pharmacologic classes
Ergolines [CS], Ergot Derivative [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bromocriptine Mesylate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMOCRIPTINE MESYLATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFFP983J3OD
Rxcui197411, 197412

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70954-951-10Bromocriptine Mesylate30 in 1 BOTTLECAPSULE302
70954-951-20Bromocriptine Mesylate100 in 1 BOTTLECAPSULE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-951-10EA - Each70954-951b020e95d-567a-4b6f-bc0d-de9cdf1125c512026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197411bromocriptine mesylate 2.5 MG Oral TabletPSN17f3a343-1782-4799-95ba-31dfe93be2cf2
197412bromocriptine mesylate 5 MG Oral CapsulePSN17f3a343-1782-4799-95ba-31dfe93be2cf2
197411bromocriptine 2.5 MG Oral TabletSCD17f3a343-1782-4799-95ba-31dfe93be2cf2
197412bromocriptine 5 MG Oral CapsuleSCD17f3a343-1782-4799-95ba-31dfe93be2cf2
197411bromocriptine (as bromocriptine mesylate) 2.5 MG Oral TabletSY17f3a343-1782-4799-95ba-31dfe93be2cf2
197412bromocriptine 5 MG (as bromocriptine mesylate 5.74 MG) Oral CapsuleSY17f3a343-1782-4799-95ba-31dfe93be2cf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70954-951-107095409511030 CAPSULE in 1 BOTTLE (70954-951-10) 30 capsule2026-04-06NoNoCurrent
70954-951-2070954095120100 CAPSULE in 1 BOTTLE (70954-951-20) 100 capsule2026-04-06NoNoCurrent