prednisone

Generic: prednisone

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prednisone
Generic Name prednisone
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

prednisone 5 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-0640
Product ID 0378-0640_f7cba7fb-7b9f-4464-a702-5c4f818aeb5f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080292
Listing Expiration 2026-12-31
Marketing Start 2019-03-07

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 03780640
Hyphenated Format 0378-0640

Supplemental Identifiers

RxCUI
198145 312615 312617
UPC
0303780641013 0303780640016 0303780642010
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 ANDA080292 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0378-0640-01)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0640-10)
source: ndc

Packages (2)

0378-0640-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0640-01) 0378-0640-10 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0640-10)

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": "f7cba7fb-7b9f-4464-a702-5c4f818aeb5f", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0303780641013", "0303780640016", "0303780642010"], "unii": ["VB0R961HZT"], "rxcui": ["198145", "312615", "312617"], "spl_set_id": ["fec09050-5ac2-451b-a2b9-5a21b2def212"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0640-01)", "package_ndc": "0378-0640-01", "marketing_start_date": "20190307"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0640-10)", "package_ndc": "0378-0640-10", "marketing_start_date": "20190307"}], "brand_name": "Prednisone", "product_id": "0378-0640_f7cba7fb-7b9f-4464-a702-5c4f818aeb5f", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0378-0640", "generic_name": "Prednisone", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prednisone", "active_ingredients": [{"name": "PREDNISONE", "strength": "5 mg/1"}], "application_number": "ANDA080292", "marketing_category": "ANDA", "marketing_start_date": "20190307", "listing_expiration_date": "20261231"}