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 71610-641
Product ID 71610-641_f649b29f-331d-4208-b878-16e103986fbd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080352
Listing Expiration 2026-12-31
Marketing Start 1982-01-01

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 71610641
Hyphenated Format 71610-641

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 ANDA080352 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE, PLASTIC (71610-641-60)
source: ndc

Packages (1)

71610-641-60 90 TABLET in 1 BOTTLE, PLASTIC (71610-641-60)

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": "f649b29f-331d-4208-b878-16e103986fbd", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["VB0R961HZT"], "rxcui": ["312617"], "spl_set_id": ["3e44e294-1d67-4788-ae07-5a2152d23839"], "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 (71610-641-60)", "package_ndc": "71610-641-60", "marketing_start_date": "20220324"}], "brand_name": "PredniSONE", "product_id": "71610-641_f649b29f-331d-4208-b878-16e103986fbd", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "71610-641", "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": "ANDA080352", "marketing_category": "ANDA", "marketing_start_date": "19820101", "listing_expiration_date": "20261231"}