fluoxetine hydrochloride

Generic: fluoxetine hydrochloride

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

Drug Facts

Product Profile

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

fluoxetine hydrochloride 20 mg/5mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-600
Product ID 70954-600_0f4f464b-d8a7-400c-ab63-f0510ba8b982
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216448
Listing Expiration 2027-12-31
Marketing Start 2022-11-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954600
Hyphenated Format 70954-600

Supplemental Identifiers

RxCUI
310386
UPC
0370954600107
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 ANDA216448 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/5mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE, PLASTIC (70954-600-10)
source: ndc

Packages (1)

70954-600-10 120 mL in 1 BOTTLE, PLASTIC (70954-600-10)

Ingredients (1)

fluoxetine hydrochloride (20 mg/5mL)

Linked Drug Pages (1)

Fluoxetine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0f4f464b-d8a7-400c-ab63-f0510ba8b982", "openfda": {"upc": ["0370954600107"], "unii": ["I9W7N6B1KJ"], "rxcui": ["310386"], "spl_set_id": ["1ffe57c3-6f70-4075-aacb-d87a3990fdea"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE, PLASTIC (70954-600-10)", "package_ndc": "70954-600-10", "marketing_start_date": "20221109"}], "brand_name": "Fluoxetine Hydrochloride", "product_id": "70954-600_0f4f464b-d8a7-400c-ab63-f0510ba8b982", "dosage_form": "SOLUTION", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "70954-600", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine Hydrochloride", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/5mL"}], "application_number": "ANDA216448", "marketing_category": "ANDA", "marketing_start_date": "20221109", "listing_expiration_date": "20271231"}