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 10 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-998
Product ID 68180-998_71041a6b-43e4-415c-a1a6-dbd55a09a0d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211653
Listing Expiration 2026-12-31
Marketing Start 2019-08-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180998
Hyphenated Format 68180-998

Supplemental Identifiers

RxCUI
248642 313990
UPC
0368180998068 0368180999065
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 ANDA211653 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68180-998-01)
  • 30 TABLET in 1 BOTTLE (68180-998-06)
source: ndc

Packages (2)

68180-998-01 100 TABLET in 1 BOTTLE (68180-998-01) 68180-998-06 30 TABLET in 1 BOTTLE (68180-998-06)

Ingredients (1)

fluoxetine hydrochloride (10 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": "71041a6b-43e4-415c-a1a6-dbd55a09a0d6", "openfda": {"upc": ["0368180998068", "0368180999065"], "unii": ["I9W7N6B1KJ"], "rxcui": ["248642", "313990"], "spl_set_id": ["dd659085-c32d-4d35-9d4b-bafa2a93f1fb"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68180-998-01)", "package_ndc": "68180-998-01", "marketing_start_date": "20190807"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68180-998-06)", "package_ndc": "68180-998-06", "marketing_start_date": "20190807"}], "brand_name": "Fluoxetine Hydrochloride", "product_id": "68180-998_71041a6b-43e4-415c-a1a6-dbd55a09a0d6", "dosage_form": "TABLET", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "68180-998", "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": "10 mg/1"}], "application_number": "ANDA211653", "marketing_category": "ANDA", "marketing_start_date": "20190807", "listing_expiration_date": "20261231"}