Bromocriptine Capsules: Package Insert / Prescribing Information - Drugs.com

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# Bromocriptine Capsules

Package insert / prescribing information
Generic name: bromocriptine mesylate
Dosage form: capsule
Drug classes: Dopaminergic antiparkinsonism agents, Prolactin inhibitors

Medically reviewed by Drugs.com. Last updated on Aug 1, 2022.

## PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-654-01 in bottle of 100 Capsules

Bromocriptine Mesylate Capsules USP, 5 mg

Rx only

100 Capsules

BROMOCRIPTINE MESYLATE bromocriptine mesylate capsule

Product Information
Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:65841-654
Route of Administration | ORAL | DEA Schedule |

Active Ingredient/Active Moiety
Ingredient Name | Basis of Strength | Strength
BROMOCRIPTINE MESYLATE (BROMOCRIPTINE) | BROMOCRIPTINE | 5 mg

Inactive Ingredients
Ingredient Name | Strength
ALCOHOL |
AMMONIA |
BUTYL ALCOHOL |
CARRAGEENAN |
FERRIC OXIDE RED |
FERROSOFERRIC OXIDE |
HYPROMELLOSE 2910 (15 MPA.S) |
ISOPROPYL ALCOHOL |
LACTOSE MONOHYDRATE |
MAGNESIUM STEARATE |
MALEIC ACID |
POTASSIUM HYDROXIDE |
PROPYLENE GLYCOL |
SHELLAC |
SILICON DIOXIDE |
TITANIUM DIOXIDE |
WATER |

Product Characteristics
Color | BROWN (TAN) , WHITE (WHITE) | Score | no score
Shape | CAPSULE (CAPSULE) | Size | 16mm
Flavor |  | Imprint Code | ZA17;5mg
Contains |

Packaging
# | Item Code | Package Description
1 | NDC:65841-654-06 | 30 CAPSULE in 1 BOTTLE
2 | NDC:65841-654-01 | 100 CAPSULE in 1 BOTTLE

Marketing Information
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date
ANDA | ANDA078899 | 01/23/2009 |

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Establishment
Name | Address | ID/FEI | Operations
Zydus Lifesciences Limited |  | 918596198 | ANALYSIS(65841-654), MANUFACTURE(65841-654)

Zydus Lifesciences Limited

## Related/similar drugs

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## More about bromocriptine

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### Patient resources

- Drug Information

### Professional resources

- Prescribing Information
- Bromocriptine (FDA)

#### Other brands

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