prednisone tablets, usp, 10 mg

Generic: prednisone

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

Drug Facts

Product Profile

Brand Name prednisone tablets, usp, 10 mg
Generic Name prednisone
Labeler granulation technology, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

prednisone 10 mg/1

Manufacturer
Granulation Technology, Inc.

Identifiers & Regulatory

Product NDC 63561-0121
Product ID 63561-0121_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 635610121
Hyphenated Format 63561-0121

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, 10 mg (source: ndc)
Generic Name prednisone (source: ndc)
Application Number ANDA212629 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (63561-0121-1)
  • 1000 TABLET in 1 BOTTLE (63561-0121-2)
  • 500 TABLET in 1 BOTTLE (63561-0121-5)
source: ndc

Packages (3)

63561-0121-1 100 TABLET in 1 BOTTLE (63561-0121-1) 63561-0121-2 1000 TABLET in 1 BOTTLE (63561-0121-2) 63561-0121-5 500 TABLET in 1 BOTTLE (63561-0121-5)

Ingredients (1)

prednisone (10 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 (63561-0121-1)", "package_ndc": "63561-0121-1", "marketing_start_date": "20250522"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (63561-0121-2)", "package_ndc": "63561-0121-2", "marketing_start_date": "20250522"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (63561-0121-5)", "package_ndc": "63561-0121-5", "marketing_start_date": "20250522"}], "brand_name": "PredniSONE Tablets, USP, 10 mg", "product_id": "63561-0121_3c696af0-7946-dd78-e063-6394a90a71cc", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "63561-0121", "generic_name": "PredniSONE", "labeler_name": "Granulation Technology, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PredniSONE Tablets, USP, 10 mg", "active_ingredients": [{"name": "PREDNISONE", "strength": "10 mg/1"}], "application_number": "ANDA212629", "marketing_category": "ANDA", "marketing_start_date": "20250522", "listing_expiration_date": "20261231"}