prednisolone acetate

Generic: prednisolone acetate

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

prednisolone acetate 10 mg/mL

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70748-332
Product ID 70748-332_8b7144d6-fff1-4afd-a80b-332ff7ed80a1
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 70748332
Hyphenated Format 70748-332

Supplemental Identifiers

RxCUI
1376336
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 ANDA216935 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70748-332-02) / 5 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (70748-332-03) / 10 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (70748-332-04) / 15 mL in 1 BOTTLE
source: ndc

Packages (3)

70748-332-02 1 BOTTLE in 1 CARTON (70748-332-02) / 5 mL in 1 BOTTLE 70748-332-03 1 BOTTLE in 1 CARTON (70748-332-03) / 10 mL in 1 BOTTLE 70748-332-04 1 BOTTLE in 1 CARTON (70748-332-04) / 15 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": "8b7144d6-fff1-4afd-a80b-332ff7ed80a1", "openfda": {"unii": ["8B2807733D"], "rxcui": ["1376336"], "spl_set_id": ["75fbeab1-ce8d-4999-a875-472174be5cc6"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70748-332-02)  / 5 mL in 1 BOTTLE", "package_ndc": "70748-332-02", "marketing_start_date": "20241011"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (70748-332-03)  / 10 mL in 1 BOTTLE", "package_ndc": "70748-332-03", "marketing_start_date": "20241011"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (70748-332-04)  / 15 mL in 1 BOTTLE", "package_ndc": "70748-332-04", "marketing_start_date": "20241011"}], "brand_name": "PREDNISOLONE ACETATE", "product_id": "70748-332_8b7144d6-fff1-4afd-a80b-332ff7ed80a1", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "70748-332", "generic_name": "prednisolone acetate", "labeler_name": "Lupin Pharmaceuticals, Inc.", "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"}