fluoxetine hydrochloride

Generic: fluoxetine hydrochloride

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine hydrochloride
Generic Name fluoxetine hydrochloride
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 60 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-997
Product ID 68180-997_e905b16a-58b6-4211-9931-dd2047db998a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211632
Listing Expiration 2026-12-31
Marketing Start 2019-04-09

Pharmacologic Class

Classes
serotonin reuptake inhibitor [epc] serotonin uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180997
Hyphenated Format 68180-997

Supplemental Identifiers

RxCUI
1190110
UPC
0368180997061
UNII
I9W7N6B1KJ

Packaging Origin

Original Packager
true

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 fluoxetine hydrochloride (source: ndc)
Generic Name fluoxetine hydrochloride (source: ndc)
Application Number ANDA211632 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68180-997-06)
source: ndc

Packages (1)

68180-997-06 30 TABLET in 1 BOTTLE (68180-997-06)

Ingredients (1)

fluoxetine hydrochloride (60 mg/1)

Linked Drug Pages (1)

Fluoxetine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e905b16a-58b6-4211-9931-dd2047db998a", "openfda": {"upc": ["0368180997061"], "unii": ["I9W7N6B1KJ"], "rxcui": ["1190110"], "spl_set_id": ["f274f102-67ec-46e7-b248-533be2e3003b"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68180-997-06)", "package_ndc": "68180-997-06", "marketing_start_date": "20190409"}], "brand_name": "Fluoxetine Hydrochloride", "product_id": "68180-997_e905b16a-58b6-4211-9931-dd2047db998a", "dosage_form": "TABLET", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "68180-997", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine Hydrochloride", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA211632", "marketing_category": "ANDA", "marketing_start_date": "20190409", "listing_expiration_date": "20261231"}