prednisone

Generic: prednisone

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

Drug Facts

Product Profile

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

prednisone 5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-486
Product ID 59651-486_d957f055-4838-49e6-ae32-604fb3056bc4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215672
Listing Expiration 2026-12-31
Marketing Start 2022-03-28

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 59651486
Hyphenated Format 59651-486

Supplemental Identifiers

RxCUI
198145 198146 198148 312615 312617
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 ANDA215672 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (59651-486-01)
  • 10 BLISTER PACK in 1 CARTON (59651-486-78) / 10 TABLET in 1 BLISTER PACK
  • 1000 TABLET in 1 BOTTLE (59651-486-99)
source: ndc

Packages (3)

59651-486-01 100 TABLET in 1 BOTTLE (59651-486-01) 59651-486-78 10 BLISTER PACK in 1 CARTON (59651-486-78) / 10 TABLET in 1 BLISTER PACK 59651-486-99 1000 TABLET in 1 BOTTLE (59651-486-99)

Ingredients (1)

prednisone (5 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": "d957f055-4838-49e6-ae32-604fb3056bc4", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["VB0R961HZT"], "rxcui": ["198145", "198146", "198148", "312615", "312617"], "spl_set_id": ["b1ac4c92-e1fd-4015-b172-0932790ae019"], "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 (59651-486-01)", "package_ndc": "59651-486-01", "marketing_start_date": "20220328"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (59651-486-78)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "59651-486-78", "marketing_start_date": "20220328"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (59651-486-99)", "package_ndc": "59651-486-99", "marketing_start_date": "20220328"}], "brand_name": "PREDNISONE", "product_id": "59651-486_d957f055-4838-49e6-ae32-604fb3056bc4", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "59651-486", "generic_name": "PREDNISONE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PREDNISONE", "active_ingredients": [{"name": "PREDNISONE", "strength": "5 mg/1"}], "application_number": "ANDA215672", "marketing_category": "ANDA", "marketing_start_date": "20220328", "listing_expiration_date": "20261231"}