fluoxetine

Generic: fluoxetine

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

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler alembic pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 10 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-022
Product ID 62332-022_88b2df81-f3ba-4455-8dc5-8fd2eb4929f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090223
Listing Expiration 2026-12-31
Marketing Start 2016-01-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62332022
Hyphenated Format 62332-022

Supplemental Identifiers

RxCUI
310384 310385 313989
UPC
0362332023301 0362332024308
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 (source: ndc)
Generic Name fluoxetine (source: ndc)
Application Number ANDA090223 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (62332-022-30)
  • 100 CAPSULE in 1 BOTTLE (62332-022-31)
  • 1000 CAPSULE in 1 BOTTLE (62332-022-91)
source: ndc

Packages (3)

62332-022-30 30 CAPSULE in 1 BOTTLE (62332-022-30) 62332-022-31 100 CAPSULE in 1 BOTTLE (62332-022-31) 62332-022-91 1000 CAPSULE in 1 BOTTLE (62332-022-91)

Ingredients (1)

fluoxetine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Fluoxetine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "88b2df81-f3ba-4455-8dc5-8fd2eb4929f3", "openfda": {"upc": ["0362332023301", "0362332024308"], "unii": ["I9W7N6B1KJ"], "rxcui": ["310384", "310385", "313989"], "spl_set_id": ["9de65da4-73f8-4c88-8198-c92e63224ddb"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (62332-022-30)", "package_ndc": "62332-022-30", "marketing_start_date": "20160129"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (62332-022-31)", "package_ndc": "62332-022-31", "marketing_start_date": "20160129"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (62332-022-91)", "package_ndc": "62332-022-91", "marketing_start_date": "20160129"}], "brand_name": "Fluoxetine", "product_id": "62332-022_88b2df81-f3ba-4455-8dc5-8fd2eb4929f3", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "62332-022", "generic_name": "Fluoxetine", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090223", "marketing_category": "ANDA", "marketing_start_date": "20160129", "listing_expiration_date": "20261231"}