fluoxetine hydrochloride

Generic: fluoxetine hydrochloride

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

Drug Facts

Product Profile

Brand Name fluoxetine hydrochloride
Generic Name fluoxetine hydrochloride
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-243
Product ID 46708-243_563f5910-59e7-46c6-9b3d-d9c9b0efb350
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208698
Listing Expiration 2026-12-31
Marketing Start 2017-04-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708243
Hyphenated Format 46708-243

Supplemental Identifiers

RxCUI
248642 313990
UPC
0346708242305
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 ANDA208698 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (46708-243-30)
  • 100 TABLET, FILM COATED in 1 BOTTLE (46708-243-31)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (46708-243-91)
source: ndc

Packages (3)

46708-243-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-243-30) 46708-243-31 100 TABLET, FILM COATED in 1 BOTTLE (46708-243-31) 46708-243-91 1000 TABLET, FILM COATED in 1 BOTTLE (46708-243-91)

Ingredients (1)

fluoxetine hydrochloride (20 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": "563f5910-59e7-46c6-9b3d-d9c9b0efb350", "openfda": {"upc": ["0346708242305"], "unii": ["I9W7N6B1KJ"], "rxcui": ["248642", "313990"], "spl_set_id": ["9c5112c0-c721-4086-9a75-3b7f931430bb"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (46708-243-30)", "package_ndc": "46708-243-30", "marketing_start_date": "20170415"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (46708-243-31)", "package_ndc": "46708-243-31", "marketing_start_date": "20170415"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (46708-243-91)", "package_ndc": "46708-243-91", "marketing_start_date": "20170415"}], "brand_name": "Fluoxetine Hydrochloride", "product_id": "46708-243_563f5910-59e7-46c6-9b3d-d9c9b0efb350", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "46708-243", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine Hydrochloride", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA208698", "marketing_category": "ANDA", "marketing_start_date": "20170415", "listing_expiration_date": "20261231"}