prednisolone acetate

Generic: prednisolone acetate

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name prednisolone acetate
Generic Name prednisolone acetate
Labeler asclemed usa, inc.
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

prednisolone acetate 10 mg/mL

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-204
Product ID 76420-204_d1fbb852-8bc5-7a0e-e053-2a95a90a2d8e
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 76420204
Hyphenated Format 76420-204

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 (76420-204-05) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

76420-204-05 1 BOTTLE, DROPPER in 1 CARTON (76420-204-05) / 5 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": "d1fbb852-8bc5-7a0e-e053-2a95a90a2d8e", "openfda": {"unii": ["8B2807733D"], "rxcui": ["1376336"], "spl_set_id": ["232e40a5-17c5-4cf3-9e3b-110a194ad4be"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (76420-204-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "76420-204-05", "marketing_start_date": "20211130"}], "brand_name": "PREDNISOLONE ACETATE", "product_id": "76420-204_d1fbb852-8bc5-7a0e-e053-2a95a90a2d8e", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "76420-204", "generic_name": "prednisolone acetate", "labeler_name": "Asclemed USA, Inc.", "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"}