prednisone

Generic: prednisone

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prednisone
Generic Name prednisone
Labeler actavis pharma, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

prednisone 10 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-5442
Product ID 0591-5442_6e6cf2e7-c839-4c9f-a58a-fea5023fb432
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA085162
Listing Expiration 2026-12-31
Marketing Start 1990-01-01

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 05915442
Hyphenated Format 0591-5442

Supplemental Identifiers

RxCUI
198145 312615 312617 763179 763181 763183 763185
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 ANDA085162 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0591-5442-01)
  • 500 TABLET in 1 BOTTLE (0591-5442-05)
  • 1000 TABLET in 1 BOTTLE (0591-5442-10)
  • 1 BLISTER PACK in 1 CARTON (0591-5442-21) / 21 TABLET in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (0591-5442-43) / 48 TABLET in 1 BLISTER PACK
source: ndc

Packages (5)

0591-5442-01 100 TABLET in 1 BOTTLE (0591-5442-01) 0591-5442-05 500 TABLET in 1 BOTTLE (0591-5442-05) 0591-5442-10 1000 TABLET in 1 BOTTLE (0591-5442-10) 0591-5442-21 1 BLISTER PACK in 1 CARTON (0591-5442-21) / 21 TABLET in 1 BLISTER PACK 0591-5442-43 1 BLISTER PACK in 1 CARTON (0591-5442-43) / 48 TABLET in 1 BLISTER PACK

Ingredients (1)

prednisone (10 mg/1)

Linked Drug Pages (1)

Prednisone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6e6cf2e7-c839-4c9f-a58a-fea5023fb432", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["VB0R961HZT"], "rxcui": ["198145", "312615", "312617", "763179", "763181", "763183", "763185"], "spl_set_id": ["aa0b1582-6ef3-4697-9ea6-5391e6e57853"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0591-5442-01)", "package_ndc": "0591-5442-01", "marketing_start_date": "19900101"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0591-5442-05)", "package_ndc": "0591-5442-05", "marketing_start_date": "19900101"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (0591-5442-10)", "package_ndc": "0591-5442-10", "marketing_start_date": "19930518"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0591-5442-21)  / 21 TABLET in 1 BLISTER PACK", "package_ndc": "0591-5442-21", "marketing_start_date": "20160525"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0591-5442-43)  / 48 TABLET in 1 BLISTER PACK", "package_ndc": "0591-5442-43", "marketing_start_date": "20160525"}], "brand_name": "Prednisone", "product_id": "0591-5442_6e6cf2e7-c839-4c9f-a58a-fea5023fb432", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0591-5442", "generic_name": "Prednisone", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prednisone", "active_ingredients": [{"name": "PREDNISONE", "strength": "10 mg/1"}], "application_number": "ANDA085162", "marketing_category": "ANDA", "marketing_start_date": "19900101", "listing_expiration_date": "20261231"}