prednisone

Generic: prednisone

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

Drug Facts

Product Profile

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

prednisone 5 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3581
Product ID 68071-3581_1289ccc0-8def-ceab-e063-6294a90ac106
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080352
Listing Expiration 2026-12-31
Marketing Start 2020-03-23

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 680713581
Hyphenated Format 68071-3581

Supplemental Identifiers

RxCUI
312617
UPC
0368071358117
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
  • 100 TABLET in 1 BOTTLE (68071-3581-1)
source: ndc

Packages (1)

68071-3581-1 100 TABLET in 1 BOTTLE (68071-3581-1)

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": "1289ccc0-8def-ceab-e063-6294a90ac106", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0368071358117"], "unii": ["VB0R961HZT"], "rxcui": ["312617"], "spl_set_id": ["1289c6d2-2707-baca-e063-6294a90a750d"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68071-3581-1)", "package_ndc": "68071-3581-1", "marketing_start_date": "20240229"}], "brand_name": "PredniSONE", "product_id": "68071-3581_1289ccc0-8def-ceab-e063-6294a90ac106", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68071-3581", "generic_name": "PredniSONE", "labeler_name": "NuCare 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": "20200323", "listing_expiration_date": "20261231"}