prednisolone

Generic: prednisolone

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prednisolone
Generic Name prednisolone
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

prednisolone 5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-491
Product ID 59651-491_c535b93f-b31f-411f-848c-b5e6782f321f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215673
Listing Expiration 2026-12-31
Marketing Start 2023-03-17

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651491
Hyphenated Format 59651-491

Supplemental Identifiers

RxCUI
198142
UNII
9PHQ9Y1OLM
NUI
N0000175576 N0000175450

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 (source: ndc)
Generic Name prednisolone (source: ndc)
Application Number ANDA215673 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (59651-491-01)
  • 50 TABLET in 1 BOTTLE (59651-491-50)
source: ndc

Packages (2)

59651-491-01 100 TABLET in 1 BOTTLE (59651-491-01) 59651-491-50 50 TABLET in 1 BOTTLE (59651-491-50)

Ingredients (1)

prednisolone (5 mg/1)

Linked Drug Pages (1)

PREDNISOLONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c535b93f-b31f-411f-848c-b5e6782f321f", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["9PHQ9Y1OLM"], "rxcui": ["198142"], "spl_set_id": ["070f1937-50a5-457f-bef5-4e597014e26d"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (59651-491-01)", "package_ndc": "59651-491-01", "marketing_start_date": "20230317"}, {"sample": false, "description": "50 TABLET in 1 BOTTLE (59651-491-50)", "package_ndc": "59651-491-50", "marketing_start_date": "20230317"}], "brand_name": "PREDNISOLONE", "product_id": "59651-491_c535b93f-b31f-411f-848c-b5e6782f321f", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "59651-491", "generic_name": "PREDNISOLONE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PREDNISOLONE", "active_ingredients": [{"name": "PREDNISOLONE", "strength": "5 mg/1"}], "application_number": "ANDA215673", "marketing_category": "ANDA", "marketing_start_date": "20230317", "listing_expiration_date": "20261231"}