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 87063-044
Product ID 87063-044_4a1001c0-0013-e6a5-e063-6294a90af48e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215672
Listing Expiration 2027-12-31
Marketing Start 2022-03-28

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 87063044
Hyphenated Format 87063-044

Supplemental Identifiers

RxCUI
198145 198146 198148 312615 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 ANDA215672 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (87063-044-01)
  • 18 TABLET in 1 BOTTLE (87063-044-18)
  • 20 TABLET in 1 BOTTLE (87063-044-20)
  • 21 TABLET in 1 BOTTLE (87063-044-21)
  • 30 TABLET in 1 BOTTLE (87063-044-30)
  • 60 TABLET in 1 BOTTLE (87063-044-60)
  • 10 BLISTER PACK in 1 CARTON (87063-044-78) / 10 TABLET in 1 BLISTER PACK
  • 90 TABLET in 1 BOTTLE (87063-044-90)
source: ndc

Packages (8)

87063-044-01 100 TABLET in 1 BOTTLE (87063-044-01) 87063-044-18 18 TABLET in 1 BOTTLE (87063-044-18) 87063-044-20 20 TABLET in 1 BOTTLE (87063-044-20) 87063-044-21 21 TABLET in 1 BOTTLE (87063-044-21) 87063-044-30 30 TABLET in 1 BOTTLE (87063-044-30) 87063-044-60 60 TABLET in 1 BOTTLE (87063-044-60) 87063-044-78 10 BLISTER PACK in 1 CARTON (87063-044-78) / 10 TABLET in 1 BLISTER PACK 87063-044-90 90 TABLET in 1 BOTTLE (87063-044-90)

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": "4a1001c0-0013-e6a5-e063-6294a90af48e", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["VB0R961HZT"], "rxcui": ["198145", "198146", "198148", "312615", "312617"], "spl_set_id": ["bf6ebe58-e7bb-49d3-842e-3372f8ba6172"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["ASCLEMED USA INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (87063-044-01)", "package_ndc": "87063-044-01", "marketing_start_date": "20251203"}, {"sample": false, "description": "18 TABLET in 1 BOTTLE (87063-044-18)", "package_ndc": "87063-044-18", "marketing_start_date": "20251203"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (87063-044-20)", "package_ndc": "87063-044-20", "marketing_start_date": "20251203"}, {"sample": false, "description": "21 TABLET in 1 BOTTLE (87063-044-21)", "package_ndc": "87063-044-21", "marketing_start_date": "20251203"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (87063-044-30)", "package_ndc": "87063-044-30", "marketing_start_date": "20251203"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (87063-044-60)", "package_ndc": "87063-044-60", "marketing_start_date": "20251203"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (87063-044-78)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "87063-044-78", "marketing_start_date": "20251203"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (87063-044-90)", "package_ndc": "87063-044-90", "marketing_start_date": "20251203"}], "brand_name": "PREDNISONE", "product_id": "87063-044_4a1001c0-0013-e6a5-e063-6294a90af48e", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "87063-044", "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": "ANDA215672", "marketing_category": "ANDA", "marketing_start_date": "20220328", "listing_expiration_date": "20271231"}