prednisolone

Generic: prednisolone

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prednisolone
Generic Name prednisolone
Labeler a-s medication solutions
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

prednisolone 15 mg/5mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7115
Product ID 50090-7115_9a49f696-0cdf-45d7-adc4-f1cb1fbb690b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040571
Listing Expiration 2027-12-31
Marketing Start 2023-09-12

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 500907115
Hyphenated Format 50090-7115

Supplemental Identifiers

RxCUI
283077
UNII
9PHQ9Y1OLM
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 prednisolone (source: ndc)
Generic Name prednisolone (source: ndc)
Application Number ANDA040571 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/5mL
source: ndc
Packaging
  • 2 BOTTLE, DISPENSING in 1 BOTTLE (50090-7115-0) / 120 mL in 1 BOTTLE, DISPENSING
  • 4 BOTTLE, DISPENSING in 1 BOTTLE (50090-7115-1) / 60 mL in 1 BOTTLE, DISPENSING
source: ndc

Packages (2)

50090-7115-0 2 BOTTLE, DISPENSING in 1 BOTTLE (50090-7115-0) / 120 mL in 1 BOTTLE, DISPENSING 50090-7115-1 4 BOTTLE, DISPENSING in 1 BOTTLE (50090-7115-1) / 60 mL in 1 BOTTLE, DISPENSING

Ingredients (1)

prednisolone (15 mg/5mL)

Linked Drug Pages (1)

Prednisolone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9a49f696-0cdf-45d7-adc4-f1cb1fbb690b", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["9PHQ9Y1OLM"], "rxcui": ["283077"], "spl_set_id": ["35f0b197-c3ae-445a-8da7-9ffcd4472e05"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE, DISPENSING in 1 BOTTLE (50090-7115-0)  / 120 mL in 1 BOTTLE, DISPENSING", "package_ndc": "50090-7115-0", "marketing_start_date": "20240312"}, {"sample": false, "description": "4 BOTTLE, DISPENSING in 1 BOTTLE (50090-7115-1)  / 60 mL in 1 BOTTLE, DISPENSING", "package_ndc": "50090-7115-1", "marketing_start_date": "20240312"}], "brand_name": "Prednisolone", "product_id": "50090-7115_9a49f696-0cdf-45d7-adc4-f1cb1fbb690b", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "50090-7115", "generic_name": "Prednisolone", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prednisolone", "active_ingredients": [{"name": "PREDNISOLONE", "strength": "15 mg/5mL"}], "application_number": "ANDA040571", "marketing_category": "ANDA", "marketing_start_date": "20230912", "listing_expiration_date": "20271231"}