prednisolone

Generic: prednisolone

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

Drug Facts

Product Profile

Brand Name prednisolone
Generic Name prednisolone
Labeler hisun pharmaceuticals usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

prednisolone 5 mg/1

Manufacturer
Hisun Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 42658-160
Product ID 42658-160_9f93400d-a8c0-435a-ad65-48717cc455cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218083
Listing Expiration 2026-12-31
Marketing Start 2024-09-01

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 42658160
Hyphenated Format 42658-160

Supplemental Identifiers

RxCUI
198142
UPC
0342658160058
UNII
9PHQ9Y1OLM
NUI
N0000175576 N0000175450

Packaging Origin

Original Packager
true

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 prednisolone (source: ndc)
Generic Name prednisolone (source: ndc)
Application Number ANDA218083 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (42658-160-05)
source: ndc

Packages (1)

42658-160-05 100 TABLET in 1 BOTTLE (42658-160-05)

Ingredients (1)

prednisolone (5 mg/1)

Linked Drug Pages (1)

PREDNISOLONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9f93400d-a8c0-435a-ad65-48717cc455cf", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0342658160058"], "unii": ["9PHQ9Y1OLM"], "rxcui": ["198142"], "spl_set_id": ["16d4e064-66d3-4497-8c7d-3aa355f91e1d"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Hisun Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42658-160-05)", "package_ndc": "42658-160-05", "marketing_start_date": "20240901"}], "brand_name": "PREDNISOLONE", "product_id": "42658-160_9f93400d-a8c0-435a-ad65-48717cc455cf", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "42658-160", "generic_name": "PREDNISOLONE", "labeler_name": "Hisun Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PREDNISOLONE", "active_ingredients": [{"name": "PREDNISOLONE", "strength": "5 mg/1"}], "application_number": "ANDA218083", "marketing_category": "ANDA", "marketing_start_date": "20240901", "listing_expiration_date": "20261231"}