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 71610-834
Product ID 71610-834_1dff4f38-127c-459d-e063-6394a90a4bdb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211575
Listing Expiration 2026-12-31
Marketing Start 2023-02-01

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 71610834
Hyphenated Format 71610-834

Supplemental Identifiers

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 ANDA211575 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71610-834-30)
  • 60 TABLET in 1 BOTTLE (71610-834-53)
  • 90 TABLET in 1 BOTTLE (71610-834-60)
  • 180 TABLET in 1 BOTTLE (71610-834-80)
source: ndc

Packages (4)

71610-834-30 30 TABLET in 1 BOTTLE (71610-834-30) 71610-834-53 60 TABLET in 1 BOTTLE (71610-834-53) 71610-834-60 90 TABLET in 1 BOTTLE (71610-834-60) 71610-834-80 180 TABLET in 1 BOTTLE (71610-834-80)

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": "1dff4f38-127c-459d-e063-6394a90a4bdb", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["VB0R961HZT"], "spl_set_id": ["18818282-68aa-82e9-e063-6394a90aef54"], "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": "30 TABLET in 1 BOTTLE (71610-834-30)", "package_ndc": "71610-834-30", "marketing_start_date": "20240513"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-834-53)", "package_ndc": "71610-834-53", "marketing_start_date": "20240513"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-834-60)", "package_ndc": "71610-834-60", "marketing_start_date": "20240513"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-834-80)", "package_ndc": "71610-834-80", "marketing_start_date": "20240718"}], "brand_name": "Prednisone", "product_id": "71610-834_1dff4f38-127c-459d-e063-6394a90a4bdb", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "71610-834", "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": "ANDA211575", "marketing_category": "ANDA", "marketing_start_date": "20230201", "listing_expiration_date": "20261231"}