prednisone

Generic: prednisone

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prednisone
Generic Name prednisone
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

prednisone 5 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 67544-399
Product ID 67544-399_4e4b9eb1-c341-44b9-a496-590eb2c5c7e6
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 67544399
Hyphenated Format 67544-399

Supplemental Identifiers

RxCUI
312617
UNII
VB0R961HZT
NUI
N0000175576 N0000175450

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
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE, PLASTIC (67544-399-60)
source: ndc

Packages (1)

67544-399-60 90 TABLET in 1 BOTTLE, PLASTIC (67544-399-60)

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": "4e4b9eb1-c341-44b9-a496-590eb2c5c7e6", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["VB0R961HZT"], "rxcui": ["312617"], "spl_set_id": ["b902ed21-c776-4046-8fbc-9ce95b16b139"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (67544-399-60)", "package_ndc": "67544-399-60", "marketing_start_date": "20171221"}], "brand_name": "Prednisone", "product_id": "67544-399_4e4b9eb1-c341-44b9-a496-590eb2c5c7e6", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "67544-399", "generic_name": "Prednisone", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prednisone", "active_ingredients": [{"name": "PREDNISONE", "strength": "5 mg/1"}], "application_number": "ANDA040256", "marketing_category": "ANDA", "marketing_start_date": "20020712", "listing_expiration_date": "20261231"}