prednisone

Generic: prednisone

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prednisone
Generic Name prednisone
Labeler endo usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

prednisone 10 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 0603-5338
Product ID 0603-5338_e6628b5c-a3e4-462b-a01a-695ed8d3ab64
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040256
Listing Expiration 2026-12-31
Marketing Start 2002-07-12

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 06035338
Hyphenated Format 0603-5338

Supplemental Identifiers

RxCUI
198144 198145 198146 312615 312617 763179 763181 763183 763185
UPC
0306035335217 0306035339215 0306035338218
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 ANDA040256 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 21 TABLET in 1 BOX, UNIT-DOSE (0603-5338-15)
  • 100 TABLET in 1 BOTTLE, PLASTIC (0603-5338-21)
  • 500 TABLET in 1 BOTTLE, PLASTIC (0603-5338-28)
  • 48 TABLET in 1 BOX, UNIT-DOSE (0603-5338-31)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (0603-5338-32)
source: ndc

Packages (5)

0603-5338-15 21 TABLET in 1 BOX, UNIT-DOSE (0603-5338-15) 0603-5338-21 100 TABLET in 1 BOTTLE, PLASTIC (0603-5338-21) 0603-5338-28 500 TABLET in 1 BOTTLE, PLASTIC (0603-5338-28) 0603-5338-31 48 TABLET in 1 BOX, UNIT-DOSE (0603-5338-31) 0603-5338-32 1000 TABLET in 1 BOTTLE, PLASTIC (0603-5338-32)

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": "e6628b5c-a3e4-462b-a01a-695ed8d3ab64", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0306035335217", "0306035339215", "0306035338218"], "unii": ["VB0R961HZT"], "rxcui": ["198144", "198145", "198146", "312615", "312617", "763179", "763181", "763183", "763185"], "spl_set_id": ["10fe5a3b-84dc-4600-87c2-b80c97ce18cf"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "21 TABLET in 1 BOX, UNIT-DOSE (0603-5338-15)", "package_ndc": "0603-5338-15", "marketing_start_date": "20020712"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0603-5338-21)", "package_ndc": "0603-5338-21", "marketing_start_date": "20020712"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (0603-5338-28)", "package_ndc": "0603-5338-28", "marketing_start_date": "20020712"}, {"sample": false, "description": "48 TABLET in 1 BOX, UNIT-DOSE (0603-5338-31)", "package_ndc": "0603-5338-31", "marketing_start_date": "20020712"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (0603-5338-32)", "package_ndc": "0603-5338-32", "marketing_start_date": "20020712"}], "brand_name": "Prednisone", "product_id": "0603-5338_e6628b5c-a3e4-462b-a01a-695ed8d3ab64", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0603-5338", "generic_name": "Prednisone", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prednisone", "active_ingredients": [{"name": "PREDNISONE", "strength": "10 mg/1"}], "application_number": "ANDA040256", "marketing_category": "ANDA", "marketing_start_date": "20020712", "listing_expiration_date": "20261231"}