Paroxetine

Product NDC

68071-4315

11-digit product format

680714315

Labeler code

68071

Product ID

68071-4315_66d52ffb-7473-6de9-e053-2a91aa0a909b

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

paroxetine hydrochloride hemihydrate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

NuCare Pharmaceuticals,Inc.

Application

ANDA205528

Marketing category

ANDA

Marketing start

2015-11-20

Marketing end

0000-00-00

Substance

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Active strength

20 mg/1

Pharmacologic classes

Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record