prednisone

Generic: prednisone

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prednisone
Generic Name prednisone
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

prednisone 10 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-412
Product ID 76420-412_4c2b2c5f-3f84-9799-e063-6294a90a37cb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208412
Listing Expiration 2027-12-31
Marketing Start 2021-09-01

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 76420412
Hyphenated Format 76420-412

Supplemental Identifiers

RxCUI
198145 198148 312615
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 ANDA208412 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE, PLASTIC (76420-412-00)
  • 100 TABLET in 1 BOTTLE, PLASTIC (76420-412-01)
  • 5 TABLET in 1 BOTTLE, PLASTIC (76420-412-05)
  • 10 TABLET in 1 BOTTLE, PLASTIC (76420-412-10)
  • 18 TABLET in 1 BOTTLE, PLASTIC (76420-412-18)
  • 20 TABLET in 1 BOTTLE, PLASTIC (76420-412-20)
  • 21 TABLET in 1 BOTTLE, PLASTIC (76420-412-21)
  • 30 TABLET in 1 BOTTLE, PLASTIC (76420-412-30)
  • 500 TABLET in 1 BOTTLE, PLASTIC (76420-412-50)
  • 60 TABLET in 1 BOTTLE, PLASTIC (76420-412-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (76420-412-90)
source: ndc

Packages (11)

76420-412-00 1000 TABLET in 1 BOTTLE, PLASTIC (76420-412-00) 76420-412-01 100 TABLET in 1 BOTTLE, PLASTIC (76420-412-01) 76420-412-05 5 TABLET in 1 BOTTLE, PLASTIC (76420-412-05) 76420-412-10 10 TABLET in 1 BOTTLE, PLASTIC (76420-412-10) 76420-412-18 18 TABLET in 1 BOTTLE, PLASTIC (76420-412-18) 76420-412-20 20 TABLET in 1 BOTTLE, PLASTIC (76420-412-20) 76420-412-21 21 TABLET in 1 BOTTLE, PLASTIC (76420-412-21) 76420-412-30 30 TABLET in 1 BOTTLE, PLASTIC (76420-412-30) 76420-412-50 500 TABLET in 1 BOTTLE, PLASTIC (76420-412-50) 76420-412-60 60 TABLET in 1 BOTTLE, PLASTIC (76420-412-60) 76420-412-90 90 TABLET in 1 BOTTLE, PLASTIC (76420-412-90)

Ingredients (1)

prednisone (10 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": "4c2b2c5f-3f84-9799-e063-6294a90a37cb", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["VB0R961HZT"], "rxcui": ["198145", "198148", "312615"], "spl_set_id": ["fdcf3271-fae7-47ef-a370-adbdc0a3cf37"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (76420-412-00)", "package_ndc": "76420-412-00", "marketing_start_date": "20250709"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (76420-412-01)", "package_ndc": "76420-412-01", "marketing_start_date": "20250709"}, {"sample": false, "description": "5 TABLET in 1 BOTTLE, PLASTIC (76420-412-05)", "package_ndc": "76420-412-05", "marketing_start_date": "20250709"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (76420-412-10)", "package_ndc": "76420-412-10", "marketing_start_date": "20260124"}, {"sample": false, "description": "18 TABLET in 1 BOTTLE, PLASTIC (76420-412-18)", "package_ndc": "76420-412-18", "marketing_start_date": "20250709"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (76420-412-20)", "package_ndc": "76420-412-20", "marketing_start_date": "20250709"}, {"sample": false, "description": "21 TABLET in 1 BOTTLE, PLASTIC (76420-412-21)", "package_ndc": "76420-412-21", "marketing_start_date": "20260128"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (76420-412-30)", "package_ndc": "76420-412-30", "marketing_start_date": "20250709"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (76420-412-50)", "package_ndc": "76420-412-50", "marketing_start_date": "20250709"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (76420-412-60)", "package_ndc": "76420-412-60", "marketing_start_date": "20250709"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (76420-412-90)", "package_ndc": "76420-412-90", "marketing_start_date": "20250709"}], "brand_name": "prednisone", "product_id": "76420-412_4c2b2c5f-3f84-9799-e063-6294a90a37cb", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "76420-412", "generic_name": "PREDNISONE", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "prednisone", "active_ingredients": [{"name": "PREDNISONE", "strength": "10 mg/1"}], "application_number": "ANDA208412", "marketing_category": "ANDA", "marketing_start_date": "20210901", "listing_expiration_date": "20271231"}