paroxetine
Generic: paroxetine
Labeler: lupin pharmaceuticals, inc.Drug Facts
Product Profile
Brand Name
paroxetine
Generic Name
paroxetine
Labeler
lupin pharmaceuticals, inc.
Dosage Form
TABLET, FILM COATED, EXTENDED RELEASE
Routes
Active Ingredients
paroxetine hydrochloride hemihydrate 12.5 mg/1
Manufacturer
Identifiers & Regulatory
Product NDC
68180-647
Product ID
68180-647_1a9bc25c-db83-42a0-851a-30212ee10cc6
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
ANDA
Application Number
ANDA204134
Listing Expiration
2026-12-31
Marketing Start
2017-03-06
Pharmacologic Class
Classes
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
68180647
Hyphenated Format
68180-647
Supplemental Identifiers
RxCUI
UNII
Packaging Origin
Original Packager
Resolved Product View
Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.
Resolved Identity
Brand Name
paroxetine (source: ndc)
Generic Name
paroxetine (source: ndc)
Application Number
ANDA204134 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 12.5 mg/1
Packaging
- 16 HOW SUPPLIED/STORAGE AND HANDLING Paroxetine extended-release tablets USP, 12.5 mg are supplied as yellow colored, round shaped, biconvex, film coated tablets imprinted with "L067" on one side and plain on other side. They are available as follows: Bottle of 30 tablets (NDC 68180-647-06) Bottle of 100 tablets (NDC 68180-647-01) Bottle of 500 tablets (NDC 68180-647-02) Bottle of 1000 tablets (NDC 68180-647-03) Paroxetine extended-release tablets USP, 25 mg are supplied as pink colored, round shaped, biconvex, film coated tablets imprinted with "L068" on one side and plain on other side. They are available as follows: Bottle of 30 tablets (NDC 68180-646-06) Bottle of 100 tablets (NDC 68180-646-01) Bottle of 500 tablets (NDC 68180-646-02) Bottle of 1000 tablets (NDC 68180-646-03) Paroxetine extended-release tablets USP, 37.5 mg are supplied as blue colored, round shaped, biconvex tablets imprinted with "L069" on one side and plain on other side. They are available as follows: Bottle of 30 tablets (NDC 68180-645-06) Bottle of 100 tablets (NDC 68180-645-01) Bottle of 500 tablets (NDC 68180-645-02) Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Paroxetine Extended-Release Tablets USP, 12.5 mg NDC 68180-647-06 BOTTLE LABEL - 30 TABLETS Paroxetine Extended-Release Tablets USP, 25 mg NDC 68180-646-06 BOTTLE LABEL - 30 TABLETS Paroxetine Extended-Release Tablets USP, 37.5 mg NDC 68180-645-06 BOTTLE LABEL - 30 TABLETS 12.5 25 37.5
Packages (0)
No package records.
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "1a9bc25c-db83-42a0-851a-30212ee10cc6", "openfda": {"unii": ["X2ELS050D8"], "rxcui": ["1738803", "1738805", "1738807"], "spl_set_id": ["d315e0da-f829-408b-be5d-2bca2e06913c"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "PAROXETINE", "product_id": "68180-647_1a9bc25c-db83-42a0-851a-30212ee10cc6", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "68180-647", "generic_name": "PAROXETINE", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PAROXETINE", "active_ingredients": [{"name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE", "strength": "12.5 mg/1"}], "application_number": "ANDA204134", "marketing_category": "ANDA", "marketing_start_date": "20170306", "listing_expiration_date": "20261231"}