fluorometholone

Generic: fluorometholone

Labeler: pacific pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name fluorometholone
Generic Name fluorometholone
Labeler pacific pharma, inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

fluorometholone 1 mg/mL

Manufacturer
Pacific Pharma, Inc.

Identifiers & Regulatory

Product NDC 60758-880
Product ID 60758-880_6dbbb0d9-cddb-4634-8273-e70e54ea4a38
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA016851
Listing Expiration 2026-12-31
Marketing Start 1997-10-31

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60758880
Hyphenated Format 60758-880

Supplemental Identifiers

RxCUI
310377
UNII
SV0CSG527L
NUI
N0000175576 N0000175450

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 fluorometholone (source: ndc)
Generic Name fluorometholone (source: ndc)
Application Number NDA016851 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (60758-880-05) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (60758-880-10) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

60758-880-05 1 BOTTLE, DROPPER in 1 CARTON (60758-880-05) / 5 mL in 1 BOTTLE, DROPPER 60758-880-10 1 BOTTLE, DROPPER in 1 CARTON (60758-880-10) / 10 mL in 1 BOTTLE, DROPPER

Ingredients (1)

fluorometholone (1 mg/mL)

Linked Drug Pages (1)

FLUOROMETHOLONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "6dbbb0d9-cddb-4634-8273-e70e54ea4a38", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["SV0CSG527L"], "rxcui": ["310377"], "spl_set_id": ["af59c420-789d-4c05-b3fc-c3f855bcac24"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Pacific Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60758-880-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "60758-880-05", "marketing_start_date": "19971031"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60758-880-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "60758-880-10", "marketing_start_date": "19971031"}], "brand_name": "FLUOROMETHOLONE", "product_id": "60758-880_6dbbb0d9-cddb-4634-8273-e70e54ea4a38", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "60758-880", "generic_name": "fluorometholone", "labeler_name": "Pacific Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUOROMETHOLONE", "active_ingredients": [{"name": "FLUOROMETHOLONE", "strength": "1 mg/mL"}], "application_number": "NDA016851", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "19971031", "listing_expiration_date": "20261231"}