0378-5035 : Finasteride 1 mg Oral Tablet, Film Coated

NDC:	0378-5035
Labeler:	Mylan Pharmaceuticals Inc.
Product Type:	Human Prescription Drug
Drug Name:	Finasteride
Dosage Form:	Oral Tablet, Film Coated
Application #:	ANDA078161
Rev. Date:	Jul 25, 2016

Appearance:

Markings:	M;F17
Shapes:	Round
Colors:	Blue
Size (mm):	6
Segments: *	1
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

• 0378-5035-77: 90 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑5035‑77)
• 0378-5035-93: 30 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑5035‑93)

Active Ingredients:

• Finasteride

Inactive Ingredients:

• Anhydrous Lactose
• Silicon Dioxide
• Croscarmellose Sodium
• Docusate Sodium
• Fd&c Blue No. 2
• Fd&c Yellow No. 6
• Hypromellose, Unspecified
• Magnesium Stearate
• Microcrystalline Cellulose
• Polydextrose
• Polyethylene Glycol, Unspecified
• Starch, Corn
• Povidone, Unspecified
• Titanium Dioxide
• Triacetin

Pharmaceutical Classes:

• 5-alpha Reductase Inhibitor [EPC]
• 5-alpha Reductase Inhibitors [MoA]

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