prednisolone acetate

Generic: prednisolone acetate

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name prednisolone acetate
Generic Name prednisolone acetate
Labeler sandoz inc
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

prednisolone acetate 10 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-637
Product ID 61314-637_32f12438-f75f-459e-a41f-34dcc8a9e4f7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA017469
Listing Expiration 2026-12-31
Marketing Start 1994-12-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61314637
Hyphenated Format 61314-637

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 NDA017469 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (61314-637-05) / 5 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (61314-637-10) / 10 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (61314-637-15) / 15 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (3)

61314-637-05 1 BOTTLE, PLASTIC in 1 CARTON (61314-637-05) / 5 mL in 1 BOTTLE, PLASTIC 61314-637-10 1 BOTTLE, PLASTIC in 1 CARTON (61314-637-10) / 10 mL in 1 BOTTLE, PLASTIC 61314-637-15 1 BOTTLE, PLASTIC in 1 CARTON (61314-637-15) / 15 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": "32f12438-f75f-459e-a41f-34dcc8a9e4f7", "openfda": {"unii": ["8B2807733D"], "rxcui": ["1376336"], "spl_set_id": ["05d205c7-8f51-46b9-a6c5-4199bc432b26"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (61314-637-05)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "61314-637-05", "marketing_start_date": "19941215"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (61314-637-10)  / 10 mL in 1 BOTTLE, PLASTIC", "package_ndc": "61314-637-10", "marketing_start_date": "19941215"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (61314-637-15)  / 15 mL in 1 BOTTLE, PLASTIC", "package_ndc": "61314-637-15", "marketing_start_date": "19941215"}], "brand_name": "Prednisolone Acetate", "product_id": "61314-637_32f12438-f75f-459e-a41f-34dcc8a9e4f7", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "61314-637", "generic_name": "Prednisolone Acetate", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prednisolone Acetate", "active_ingredients": [{"name": "PREDNISOLONE ACETATE", "strength": "10 mg/mL"}], "application_number": "NDA017469", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "19941215", "listing_expiration_date": "20261231"}