Ergomar

Basic Information

Product Name

Ergomar

FDA Product Code

10802-1202

Regulatory Information

NDC Product Code

10802-1202

Application Number

ANDA087693

Marketing Category

C73584

Effective Date

September 8, 2012

Territorial Authority

USA

FDA Title

Ergomar® Sublingual Tablets, 2 mg (Ergotamine Tartrate Sublingual Tablets, USP)

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

Crospovidone

Code: 68401960MK

Class Code: IACT

Cellulose, Microcrystalline

Code: OP1R32D61U

Class Code: IACT

Peppermint

Code: V95R5KMY2B

Class Code: IACT

Ergotamine Tartrate

Quantity: 2 mg in 1 1

Code: MRU5XH3B48

Class Code: ACTIB

Saccharin Sodium Dihydrate

Code: SB8ZUX40TY

Class Code: IACT

FD&C Blue No. 1

Code: H3R47K3TBD

Class Code: IACT

D&C Yellow No. 10

Code: 35SW5USQ3G

Class Code: IACT

Aluminum Oxide

Code: LMI26O6933

Class Code: IACT

Magnesium Stearate

Code: 70097M6I30

Class Code: IACT

Active Moieties

Ergotamine

Code: PR834Q503T

Basic Information

Regulatory Information

Company Information

Active Ingredients

Crospovidone

Cellulose, Microcrystalline

Peppermint

Saccharin Sodium Dihydrate

FD&C Blue No. 1

D&C Yellow No. 10

Aluminum Oxide

Magnesium Stearate

Active Moieties

Ergotamine