prednisone tablets, usp, 5 mg

Generic: prednisone

Labeler: granulation technology, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prednisone tablets, usp, 5 mg
Generic Name prednisone
Labeler granulation technology, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

prednisone 5 mg/1

Manufacturer
Granulation Technology, Inc.

Identifiers & Regulatory

Product NDC 63561-0120
Product ID 63561-0120_3c696af0-7946-dd78-e063-6394a90a71cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212629
Listing Expiration 2026-12-31
Marketing Start 2025-05-22

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 635610120
Hyphenated Format 63561-0120

Supplemental Identifiers

RxCUI
198145 312615 312617
UPC
0363561012012 0363561012210 0363561012159
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 tablets, usp, 5 mg (source: ndc)
Generic Name prednisone (source: ndc)
Application Number ANDA212629 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (63561-0120-1)
  • 1000 TABLET in 1 BOTTLE (63561-0120-2)
  • 500 TABLET in 1 BOTTLE (63561-0120-5)
source: ndc

Packages (3)

63561-0120-1 100 TABLET in 1 BOTTLE (63561-0120-1) 63561-0120-2 1000 TABLET in 1 BOTTLE (63561-0120-2) 63561-0120-5 500 TABLET in 1 BOTTLE (63561-0120-5)

Ingredients (1)

prednisone (5 mg/1)

Linked Drug Pages (1)

PredniSONE Tablets, USP, 5 mg, PredniSONE Tablets, USP, 10 mg, PredniSONE Tablets, USP, 20 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3c696af0-7946-dd78-e063-6394a90a71cc", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0363561012012", "0363561012210", "0363561012159"], "unii": ["VB0R961HZT"], "rxcui": ["198145", "312615", "312617"], "spl_set_id": ["a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Granulation Technology, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (63561-0120-1)", "package_ndc": "63561-0120-1", "marketing_start_date": "20250522"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (63561-0120-2)", "package_ndc": "63561-0120-2", "marketing_start_date": "20250522"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (63561-0120-5)", "package_ndc": "63561-0120-5", "marketing_start_date": "20250522"}], "brand_name": "PredniSONE Tablets, USP, 5 mg", "product_id": "63561-0120_3c696af0-7946-dd78-e063-6394a90a71cc", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "63561-0120", "generic_name": "PredniSONE", "labeler_name": "Granulation Technology, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PredniSONE Tablets, USP, 5 mg", "active_ingredients": [{"name": "PREDNISONE", "strength": "5 mg/1"}], "application_number": "ANDA212629", "marketing_category": "ANDA", "marketing_start_date": "20250522", "listing_expiration_date": "20261231"}