prednisolone acetate

Generic: prednisolone acetate

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name prednisolone acetate
Generic Name prednisolone acetate
Labeler a-s medication solutions
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

prednisolone acetate 10 mg/mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-1912
Product ID 50090-1912_b8aba180-92d1-4759-b2eb-f02bc95a2b8f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA017011
Listing Expiration 2026-12-31
Marketing Start 1997-08-19

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500901912
Hyphenated Format 50090-1912

Supplemental Identifiers

RxCUI
1376336
UNII
8B2807733D

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 prednisolone acetate (source: ndc)
Generic Name prednisolone acetate (source: ndc)
Application Number NDA017011 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (50090-1912-0) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

50090-1912-0 1 BOTTLE, DROPPER in 1 CARTON (50090-1912-0) / 10 mL in 1 BOTTLE, DROPPER

Ingredients (1)

prednisolone acetate (10 mg/mL)

Linked Drug Pages (1)

PREDNISOLONE ACETATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "b8aba180-92d1-4759-b2eb-f02bc95a2b8f", "openfda": {"unii": ["8B2807733D"], "rxcui": ["1376336"], "spl_set_id": ["388abc87-cd5a-4e88-8675-7bf0c5ce7af5"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (50090-1912-0)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "50090-1912-0", "marketing_start_date": "20150701"}], "brand_name": "PREDNISOLONE ACETATE", "product_id": "50090-1912_b8aba180-92d1-4759-b2eb-f02bc95a2b8f", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "50090-1912", "generic_name": "prednisolone acetate", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PREDNISOLONE ACETATE", "active_ingredients": [{"name": "PREDNISOLONE ACETATE", "strength": "10 mg/mL"}], "application_number": "NDA017011", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "19970819", "listing_expiration_date": "20261231"}