fluoxetine

Generic: fluoxetine hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-545
Product ID 72789-545_47e5358c-8f2a-46ab-e063-6294a90ae0d1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204597
Listing Expiration 2027-12-31
Marketing Start 2015-03-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789545
Hyphenated Format 72789-545

Supplemental Identifiers

RxCUI
310385
UPC
0372789545905
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
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-545-30)
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (72789-545-90)
source: ndc

Packages (2)

72789-545-30 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-545-30) 72789-545-90 90 CAPSULE in 1 BOTTLE, PLASTIC (72789-545-90)

Ingredients (1)

fluoxetine hydrochloride (20 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": "47e5358c-8f2a-46ab-e063-6294a90ae0d1", "openfda": {"upc": ["0372789545905"], "unii": ["I9W7N6B1KJ"], "rxcui": ["310385"], "spl_set_id": ["d26f7450-7650-43df-a63b-1fe2472882a9"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (72789-545-30)", "package_ndc": "72789-545-30", "marketing_start_date": "20260108"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (72789-545-90)", "package_ndc": "72789-545-90", "marketing_start_date": "20260106"}], "brand_name": "Fluoxetine", "product_id": "72789-545_47e5358c-8f2a-46ab-e063-6294a90ae0d1", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "72789-545", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA204597", "marketing_category": "ANDA", "marketing_start_date": "20150316", "listing_expiration_date": "20271231"}