prednisolone acetate

Generic: prednisolone acetate

Labeler: redpharm drug
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prednisolone acetate
Generic Name prednisolone acetate
Labeler redpharm drug
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

prednisolone acetate 10 mg/mL

Manufacturer
Redpharm Drug

Identifiers & Regulatory

Product NDC 67296-2176
Product ID 67296-2176_44f6dd75-df38-6985-e063-6294a90a80cd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216935
Listing Expiration 2026-12-31
Marketing Start 2024-10-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 672962176
Hyphenated Format 67296-2176

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 ANDA216935 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (67296-2176-5) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

67296-2176-5 1 BOTTLE in 1 CARTON (67296-2176-5) / 5 mL in 1 BOTTLE

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": "44f6dd75-df38-6985-e063-6294a90a80cd", "openfda": {"unii": ["8B2807733D"], "rxcui": ["1376336"], "spl_set_id": ["3dd0195c-8522-bbf9-e063-6394a90a9f3e"], "manufacturer_name": ["Redpharm Drug"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (67296-2176-5)  / 5 mL in 1 BOTTLE", "package_ndc": "67296-2176-5", "marketing_start_date": "20241011"}], "brand_name": "PREDNISOLONE ACETATE", "product_id": "67296-2176_44f6dd75-df38-6985-e063-6294a90a80cd", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "67296-2176", "generic_name": "prednisolone acetate", "labeler_name": "Redpharm Drug", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PREDNISOLONE ACETATE", "active_ingredients": [{"name": "PREDNISOLONE ACETATE", "strength": "10 mg/mL"}], "application_number": "ANDA216935", "marketing_category": "ANDA", "marketing_start_date": "20241011", "listing_expiration_date": "20261231"}