prozac

Generic: fluoxetine hydrochloride

Labeler: dista products company
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name prozac
Generic Name fluoxetine hydrochloride
Labeler dista products company
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 40 mg/1

Manufacturer
Dista Products Company

Identifiers & Regulatory

Product NDC 0777-3107
Product ID 0777-3107_e49a90e3-e7da-4377-8736-ebe9f53c3097
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018936
Marketing Start 1999-06-15
Marketing End 2027-04-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07773107
Hyphenated Format 0777-3107

Supplemental Identifiers

RxCUI
104849 205535 261287 310384 310385 313989
UPC
0307773107302 0307773104028 0307773105025
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 prozac (source: ndc)
Generic Name fluoxetine hydrochloride (source: ndc)
Application Number NDA018936 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (0777-3107-30)
source: ndc

Packages (1)

0777-3107-30 30 CAPSULE in 1 BOTTLE (0777-3107-30)

Ingredients (1)

fluoxetine hydrochloride (40 mg/1)

Linked Drug Pages (1)

Prozac ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e49a90e3-e7da-4377-8736-ebe9f53c3097", "openfda": {"upc": ["0307773107302", "0307773104028", "0307773105025"], "unii": ["I9W7N6B1KJ"], "rxcui": ["104849", "205535", "261287", "310384", "310385", "313989"], "spl_set_id": ["c88f33ed-6dfb-4c5e-bc01-d8e36dd97299"], "manufacturer_name": ["Dista Products Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (0777-3107-30)", "package_ndc": "0777-3107-30", "marketing_end_date": "20270407", "marketing_start_date": "19990615"}], "brand_name": "Prozac", "product_id": "0777-3107_e49a90e3-e7da-4377-8736-ebe9f53c3097", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "0777-3107", "generic_name": "Fluoxetine hydrochloride", "labeler_name": "Dista Products Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prozac", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "NDA018936", "marketing_category": "NDA", "marketing_end_date": "20270407", "marketing_start_date": "19990615"}