prednisone tablets, usp, 5 mg

Generic: prednisone

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

Drug Facts

Product Profile

Brand Name prednisone tablets, usp, 5 mg
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 72789-474
Product ID 72789-474_46b3601e-05c3-a7c9-e063-6394a90a20c9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212629
Listing Expiration 2026-12-31
Marketing Start 2025-05-22

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 72789474
Hyphenated Format 72789-474

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 tablets, usp, 5 mg (source: ndc)
Generic Name prednisone (source: ndc)
Application Number ANDA212629 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (72789-474-01)
  • 4 TABLET in 1 BOTTLE, PLASTIC (72789-474-04)
  • 21 TABLET in 1 BOTTLE, PLASTIC (72789-474-21)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (72789-474-95)
source: ndc

Packages (4)

72789-474-01 100 TABLET in 1 BOTTLE, PLASTIC (72789-474-01) 72789-474-04 4 TABLET in 1 BOTTLE, PLASTIC (72789-474-04) 72789-474-21 21 TABLET in 1 BOTTLE, PLASTIC (72789-474-21) 72789-474-95 1000 TABLET in 1 BOTTLE, PLASTIC (72789-474-95)

Ingredients (1)

prednisone (5 mg/1)

Linked Drug Pages (1)

PredniSONE Tablets, USP, 5 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "46b3601e-05c3-a7c9-e063-6394a90a20c9", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["VB0R961HZT"], "rxcui": ["312617"], "spl_set_id": ["d6df3295-3118-49af-be05-b1fab0d4adaa"], "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": "100 TABLET in 1 BOTTLE, PLASTIC (72789-474-01)", "package_ndc": "72789-474-01", "marketing_start_date": "20250522"}, {"sample": false, "description": "4 TABLET in 1 BOTTLE, PLASTIC (72789-474-04)", "package_ndc": "72789-474-04", "marketing_start_date": "20251224"}, {"sample": false, "description": "21 TABLET in 1 BOTTLE, PLASTIC (72789-474-21)", "package_ndc": "72789-474-21", "marketing_start_date": "20250903"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (72789-474-95)", "package_ndc": "72789-474-95", "marketing_start_date": "20250522"}], "brand_name": "PredniSONE Tablets, USP, 5 mg", "product_id": "72789-474_46b3601e-05c3-a7c9-e063-6394a90a20c9", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "72789-474", "generic_name": "PredniSONE", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PredniSONE Tablets, USP, 5 mg", "active_ingredients": [{"name": "PREDNISONE", "strength": "5 mg/1"}], "application_number": "ANDA212629", "marketing_category": "ANDA", "marketing_start_date": "20250522", "listing_expiration_date": "20261231"}