prednisone

Generic: prednisone

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

Drug Facts

Product Profile

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

prednisone 10 mg/1

Manufacturer
PharmPak, Inc.

Identifiers & Regulatory

Product NDC 54348-506
Product ID 54348-506_ea92f170-7889-dd0d-e053-2a95a90a80f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080356
Listing Expiration 2026-12-31
Marketing Start 2019-07-12

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 54348506
Hyphenated Format 54348-506

Supplemental Identifiers

RxCUI
198145
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 ANDA080356 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (54348-506-10) / 10 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-506-20) / 20 TABLET in 1 BOTTLE
source: ndc

Packages (2)

54348-506-10 1 BOTTLE in 1 BOX (54348-506-10) / 10 TABLET in 1 BOTTLE 54348-506-20 1 BOTTLE in 1 BOX (54348-506-20) / 20 TABLET in 1 BOTTLE

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": "ea92f170-7889-dd0d-e053-2a95a90a80f0", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["VB0R961HZT"], "rxcui": ["198145"], "spl_set_id": ["03aaf69f-d9c7-433c-baea-9c6eca0fe1e5"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["PharmPak, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (54348-506-10)  / 10 TABLET in 1 BOTTLE", "package_ndc": "54348-506-10", "marketing_start_date": "20190712"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-506-20)  / 20 TABLET in 1 BOTTLE", "package_ndc": "54348-506-20", "marketing_start_date": "20190712"}], "brand_name": "Prednisone", "product_id": "54348-506_ea92f170-7889-dd0d-e053-2a95a90a80f0", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "54348-506", "generic_name": "PREDNISONE", "labeler_name": "PharmPak, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prednisone", "active_ingredients": [{"name": "PREDNISONE", "strength": "10 mg/1"}], "application_number": "ANDA080356", "marketing_category": "ANDA", "marketing_start_date": "20190712", "listing_expiration_date": "20261231"}