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BROMOCRIPTINE MESYLATE

Bromocriptine Mesylate Tablets, USP Bromocriptine Mesylate Capsules, USP Rx Only

Approved
Approval ID

44cc1e5f-c509-40e6-ac51-eba6d0440b16

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 6, 2020

Manufacturers
FDA

Sun Pharmaceutical Industries, Inc.

DUNS: 146974886

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

bromocriptine mesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63304-158
Application NumberNDA017962
Product Classification
M
Marketing Category
C73594
G
Generic Name
bromocriptine mesylate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 6, 2020
FDA Product Classification

INGREDIENTS (12)

POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
BROMOCRIPTINE MESYLATEActive
Quantity: 5 mg in 1 1
Code: FFP983J3OD
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT

bromocriptine mesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63304-962
Application NumberNDA017962
Product Classification
M
Marketing Category
C73594
G
Generic Name
bromocriptine mesylate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 6, 2020
FDA Product Classification

INGREDIENTS (8)

POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
BROMOCRIPTINE MESYLATEActive
Quantity: 2.5 mg in 1 1
Code: FFP983J3OD
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALEIC ACIDInactive
Code: 91XW058U2C
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

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BROMOCRIPTINE MESYLATE - FDA Drug Approval Details