prednisolone acetate

Generic: prednisolone acetate

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

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

prednisolone acetate 10 mg/mL

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-2222
Product ID 68071-2222_1d7617a8-dae4-7892-e063-6294a90a3f9f
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 680712222
Hyphenated Format 68071-2222

Supplemental Identifiers

RxCUI
1376336
UPC
0368071222258
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 (68071-2222-5) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

68071-2222-5 1 BOTTLE, DROPPER in 1 CARTON (68071-2222-5) / 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": "1d7617a8-dae4-7892-e063-6294a90a3f9f", "openfda": {"upc": ["0368071222258"], "unii": ["8B2807733D"], "rxcui": ["1376336"], "spl_set_id": ["ab72cf3d-7660-41b1-e053-2995a90a7f44"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (68071-2222-5)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "68071-2222-5", "marketing_start_date": "20200727"}], "brand_name": "PREDNISOLONE ACETATE", "product_id": "68071-2222_1d7617a8-dae4-7892-e063-6294a90a3f9f", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68071-2222", "generic_name": "prednisolone acetate", "labeler_name": "NuCare Pharmaceuticals,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"}