68382-138 : Topiramate 25 mg Oral Tablet

NDC:	68382-138
Labeler:	Zydus Pharmaceuticals (Usa) Inc.
Product Type:	Human Prescription Drug
Drug Name:	Topiramate
Dosage Form:	Oral Tablet, Film Coated
Application #:	ANDA078235
Rev. Date:	Mar 27, 2009

Appearance:

Markings:	ZD;16
Shapes:	Round
Colors:	White
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.

ZD 16: (68084-342) Topiramate 25 mg Oral Tablet by Zydus Pharmaceuticals (Usa) Inc.

The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

68382-138-01: 100 TABLET, FILM COATED IN 1 BOTTLE (68382‑138‑01)
68382-138-05: 500 TABLET, FILM COATED IN 1 BOTTLE (68382‑138‑05)
68382-138-14: 60 TABLET, FILM COATED IN 1 BOTTLE (68382‑138‑14)
68382-138-16: 90 TABLET, FILM COATED IN 1 BOTTLE (68382‑138‑16)

Active Ingredients:

Topiramate

Dosage Strength:

25 mg

Inactive Ingredients:

Hypromelloses
Magnesium Stearate
Polyethylene Glycols
Silicon Dioxide
Sodium Starch Glycolate Type a Potato
Talc
Titanium Dioxide
Cellulose, Microcrystalline
Anhydrous Lactose

Pharmaceutical Classes:

Decreased Central Nervous System Disorganized Electrical Activity [PE]
Cytochrome P450 3A4 Inducers [MoA]
Cytochrome P450 2C19 Inhibitors [MoA]

NDC QR Code

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NDC 68382-138 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.