fluoxetine

Generic: fluoxetine hydrochloride

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

Drug Facts

Product Profile

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

fluoxetine hydrochloride 10 mg/1

Manufacturer
RADHA PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 77771-113
Product ID 77771-113_1cbec1b3-195b-66c8-e063-6294a90ad5a5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204597
Listing Expiration 2026-12-31
Marketing Start 2022-10-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 77771113
Hyphenated Format 77771-113

Supplemental Identifiers

RxCUI
310384 310385 313989
UPC
0377771115012 0377771114015 0377771114107 0377771113018 0377771113100 0377771115050
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 hydrochloride (source: ndc)
Application Number ANDA204597 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (77771-113-01)
  • 1000 CAPSULE in 1 BOTTLE (77771-113-10)
source: ndc

Packages (2)

77771-113-01 100 CAPSULE in 1 BOTTLE (77771-113-01) 77771-113-10 1000 CAPSULE in 1 BOTTLE (77771-113-10)

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": "1cbec1b3-195b-66c8-e063-6294a90ad5a5", "openfda": {"upc": ["0377771115012", "0377771114015", "0377771114107", "0377771113018", "0377771113100", "0377771115050"], "unii": ["I9W7N6B1KJ"], "rxcui": ["310384", "310385", "313989"], "spl_set_id": ["1a07ebe9-3661-4a48-b8af-9b228875166a"], "manufacturer_name": ["RADHA PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (77771-113-01)", "package_ndc": "77771-113-01", "marketing_start_date": "20221024"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (77771-113-10)", "package_ndc": "77771-113-10", "marketing_start_date": "20221024"}], "brand_name": "Fluoxetine", "product_id": "77771-113_1cbec1b3-195b-66c8-e063-6294a90ad5a5", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "77771-113", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "RADHA PHARMACEUTICALS, 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": "20221024", "listing_expiration_date": "20261231"}