71610-365 : Pregabalin 25 mg Oral Capsule

NDC:	71610-365
Labeler:	Aphena Pharma Solutions - Tennessee, LLC
Product Type:	Human Prescription Drug
Drug Name:	Pregabalin
Dosage Form:	Oral Capsule
Application #:	NDA021446
Rev. Date:	Jul 19, 2019
CSA Schedule:	CV (US) ^[1]

^[1] Schedule V Controlled Substance: Low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. (i.e. Cough preparations containing not more than 200 milligrams of Codeine per 100 milliliters or per 100 grams [such as Robitussin AC, Phenergan with Codeine], and Ezogabine). More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:

Markings:	Pfizer;PGN;25
Shapes:	Capsule
Colors:	White
Size (mm):	14
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:

71610-365-53: 60 CAPSULE IN 1 BOTTLE (71610‑365‑53)

Active Ingredients:

Pregabalin

Dosage Strength:

25 mg

Inactive Ingredients:

Lactose Monohydrate
Starch, Corn
Talc
Gelatin, Unspecified
Titanium Dioxide
Sodium Lauryl Sulfate
Silicon Dioxide
Shellac
Ferrosoferric Oxide
Propylene Glycol
Potassium Hydroxide /

NDC 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.