fluoxetine

Generic: fluoxetine hydrochloride

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

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine hydrochloride
Labeler remedyrepack inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 10 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3483
Product ID 70518-3483_3a9d64f1-ea44-5bc6-e063-6394a90a9e15
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204597
Listing Expiration 2026-12-31
Marketing Start 2022-08-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183483
Hyphenated Format 70518-3483

Supplemental Identifiers

RxCUI
310384
UNII
I9W7N6B1KJ

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 hydrochloride (source: ndc)
Application Number ANDA204597 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BLISTER PACK (70518-3483-0)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (70518-3483-1)
source: ndc

Packages (2)

70518-3483-0 30 CAPSULE in 1 BLISTER PACK (70518-3483-0) 70518-3483-1 90 CAPSULE in 1 BOTTLE, PLASTIC (70518-3483-1)

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": "3a9d64f1-ea44-5bc6-e063-6394a90a9e15", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["310384"], "spl_set_id": ["8b8fe00e-7a2f-486b-9b72-465a494d8939"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (70518-3483-0)", "package_ndc": "70518-3483-0", "marketing_start_date": "20220817"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (70518-3483-1)", "package_ndc": "70518-3483-1", "marketing_start_date": "20220920"}], "brand_name": "Fluoxetine", "product_id": "70518-3483_3a9d64f1-ea44-5bc6-e063-6394a90a9e15", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "70518-3483", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA204597", "marketing_category": "ANDA", "marketing_start_date": "20220817", "listing_expiration_date": "20261231"}