fluoxetine

Generic: fluoxetine hydrochloride

Labeler: time cap laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine hydrochloride
Labeler time cap laboratories, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 40 mg/1

Manufacturer
TIME CAP LABORATORIES, INC.

Identifiers & Regulatory

Product NDC 49483-703
Product ID 49483-703_22f2136b-5f0f-f6c7-e063-6394a90a907c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075465
Listing Expiration 2026-12-31
Marketing Start 2022-02-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49483703
Hyphenated Format 49483-703

Supplemental Identifiers

RxCUI
310384 310385 313989
UPC
0349483703030 0349483703504 0349483702019 0349483703016 0349483701012 0349483702101
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 ANDA075465 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (49483-703-01)
  • 30 CAPSULE in 1 BOTTLE (49483-703-03)
  • 500 CAPSULE in 1 BOTTLE (49483-703-50)
source: ndc

Packages (3)

49483-703-01 100 CAPSULE in 1 BOTTLE (49483-703-01) 49483-703-03 30 CAPSULE in 1 BOTTLE (49483-703-03) 49483-703-50 500 CAPSULE in 1 BOTTLE (49483-703-50)

Ingredients (1)

fluoxetine hydrochloride (40 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": "22f2136b-5f0f-f6c7-e063-6394a90a907c", "openfda": {"upc": ["0349483703030", "0349483703504", "0349483702019", "0349483703016", "0349483701012", "0349483702101"], "unii": ["I9W7N6B1KJ"], "rxcui": ["310384", "310385", "313989"], "spl_set_id": ["d7a4db7f-cdac-2b36-e053-2995a90a8d64"], "manufacturer_name": ["TIME CAP LABORATORIES, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (49483-703-01)", "package_ndc": "49483-703-01", "marketing_start_date": "20220212"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (49483-703-03)", "package_ndc": "49483-703-03", "marketing_start_date": "20220212"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (49483-703-50)", "package_ndc": "49483-703-50", "marketing_start_date": "20220212"}], "brand_name": "Fluoxetine", "product_id": "49483-703_22f2136b-5f0f-f6c7-e063-6394a90a907c", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "49483-703", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "TIME CAP LABORATORIES, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA075465", "marketing_category": "ANDA", "marketing_start_date": "20220212", "listing_expiration_date": "20261231"}