prednisone

Generic: prednisone

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prednisone
Generic Name prednisone
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

prednisone 5 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-968
Product ID 43063-968_3a21c358-f6b3-8e42-e063-6294a90a14cd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080352
Listing Expiration 2026-12-31
Marketing Start 1972-04-21

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 43063968
Hyphenated Format 43063-968

Supplemental Identifiers

RxCUI
312617
UPC
0343063968215
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 ANDA080352 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 21 TABLET in 1 BOTTLE, PLASTIC (43063-968-21)
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-968-30)
  • 55 TABLET in 1 BOTTLE, PLASTIC (43063-968-55)
source: ndc

Packages (3)

43063-968-21 21 TABLET in 1 BOTTLE, PLASTIC (43063-968-21) 43063-968-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-968-30) 43063-968-55 55 TABLET in 1 BOTTLE, PLASTIC (43063-968-55)

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": "3a21c358-f6b3-8e42-e063-6294a90a14cd", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0343063968215"], "unii": ["VB0R961HZT"], "rxcui": ["312617"], "spl_set_id": ["f4500eb6-d24a-4247-83f4-99e73346e328"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "21 TABLET in 1 BOTTLE, PLASTIC (43063-968-21)", "package_ndc": "43063-968-21", "marketing_start_date": "20190409"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-968-30)", "package_ndc": "43063-968-30", "marketing_start_date": "20190411"}, {"sample": false, "description": "55 TABLET in 1 BOTTLE, PLASTIC (43063-968-55)", "package_ndc": "43063-968-55", "marketing_start_date": "20190416"}], "brand_name": "PredniSONE", "product_id": "43063-968_3a21c358-f6b3-8e42-e063-6294a90a14cd", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "43063-968", "generic_name": "PredniSONE", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PredniSONE", "active_ingredients": [{"name": "PREDNISONE", "strength": "5 mg/1"}], "application_number": "ANDA080352", "marketing_category": "ANDA", "marketing_start_date": "19720421", "listing_expiration_date": "20261231"}