prednisone

Generic: prednisone

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prednisone
Generic Name prednisone
Labeler hikma pharmaceuticals usa inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

prednisone 5 mg/5mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-3722
Product ID 0054-3722_523ad364-8d95-4679-9290-446d61f36eb5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088703
Listing Expiration 2026-12-31
Marketing Start 1984-11-08

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 00543722
Hyphenated Format 0054-3722

Supplemental Identifiers

RxCUI
198144 198145 198146 198148 205301 312615 312617 315187
UPC
0300543722507
UNII
VB0R961HZT
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 prednisone (source: ndc)
Generic Name prednisone (source: ndc)
Application Number ANDA088703 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE (0054-3722-50)
  • 500 mL in 1 BOTTLE (0054-3722-63)
source: ndc

Packages (2)

0054-3722-50 120 mL in 1 BOTTLE (0054-3722-50) 0054-3722-63 500 mL in 1 BOTTLE (0054-3722-63)

Ingredients (1)

prednisone (5 mg/5mL)

Linked Drug Pages (1)

PredniSONE, PredniSONE Intensol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "523ad364-8d95-4679-9290-446d61f36eb5", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0300543722507"], "unii": ["VB0R961HZT"], "rxcui": ["198144", "198145", "198146", "198148", "205301", "312615", "312617", "315187"], "spl_set_id": ["3115aef0-fd50-4ec8-a064-3effb695f3f2"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (0054-3722-50)", "package_ndc": "0054-3722-50", "marketing_start_date": "19961213"}, {"sample": false, "description": "500 mL in 1 BOTTLE (0054-3722-63)", "package_ndc": "0054-3722-63", "marketing_start_date": "19841108"}], "brand_name": "PredniSONE", "product_id": "0054-3722_523ad364-8d95-4679-9290-446d61f36eb5", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0054-3722", "generic_name": "PredniSONE", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PredniSONE", "active_ingredients": [{"name": "PREDNISONE", "strength": "5 mg/5mL"}], "application_number": "ANDA088703", "marketing_category": "ANDA", "marketing_start_date": "19841108", "listing_expiration_date": "20261231"}