Bromocriptine mesylate

Product NDC
70518-4628
11-digit product format
705184628
Labeler code
70518
Product ID
70518-4628_50764f5e-e4f8-7f34-e063-6294a90a374d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bromocriptine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077646
Marketing category
ANDA
Marketing start
2026-04-24
Substance
BROMOCRIPTINE MESYLATE
Active strength
2.5 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 MESYLATE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFFP983J3OD
Rxcui197411

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
90f4f2b3-d032-9eaf-93c5-f165b5a4c90eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4628-0Bromocriptine mesylate50 in 1 BOXTABLET501
70518-4628-1Bromocriptine mesylate1 in 1 POUCHTABLET11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197411bromocriptine mesylate 2.5 MG Oral TabletPSN29827cb6-f8fe-424f-80ef-48f4ef4601221
197411bromocriptine 2.5 MG Oral TabletSCD29827cb6-f8fe-424f-80ef-48f4ef4601221
197411bromocriptine (as bromocriptine mesylate) 2.5 MG Oral TabletSY29827cb6-f8fe-424f-80ef-48f4ef4601221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4628-07051846280050 POUCH in 1 BOX (70518-4628-0) / 1 TABLET in 1 POUCH (70518-4628-1) 50 pouch2026-04-24NoNoHistorical
70518-4628-1705184628011 in 1 POUCHHistorical