prednisolone acetate

Generic: prednisolone acetate

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prednisolone acetate
Generic Name prednisolone acetate
Labeler amneal pharmaceuticals ny llc
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

prednisolone acetate 10 mg/mL

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 60219-2550
Product ID 60219-2550_b184f928-3c7a-46a0-9c67-7d2946a37868
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218256
Listing Expiration 2026-12-31
Marketing Start 2025-06-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 602192550
Hyphenated Format 60219-2550

Supplemental Identifiers

RxCUI
1376336
UPC
0360219255111 0360219255210
UNII
8B2807733D

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 prednisolone acetate (source: ndc)
Generic Name prednisolone acetate (source: ndc)
Application Number ANDA218256 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (60219-2550-1) / 5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

60219-2550-1 1 BOTTLE, PLASTIC in 1 CARTON (60219-2550-1) / 5 mL in 1 BOTTLE, PLASTIC

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": "b184f928-3c7a-46a0-9c67-7d2946a37868", "openfda": {"upc": ["0360219255111", "0360219255210"], "unii": ["8B2807733D"], "rxcui": ["1376336"], "spl_set_id": ["8d8e8f9b-4d65-426f-8c57-451001cdd849"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (60219-2550-1)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "60219-2550-1", "marketing_start_date": "20250613"}], "brand_name": "prednisolone acetate", "product_id": "60219-2550_b184f928-3c7a-46a0-9c67-7d2946a37868", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "60219-2550", "generic_name": "prednisolone acetate", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "prednisolone acetate", "active_ingredients": [{"name": "PREDNISOLONE ACETATE", "strength": "10 mg/mL"}], "application_number": "ANDA218256", "marketing_category": "ANDA", "marketing_start_date": "20250613", "listing_expiration_date": "20261231"}