prednisolone

Generic: prednisolone

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prednisolone
Generic Name prednisolone
Labeler proficient rx lp
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

prednisolone 15 mg/5mL

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-466
Product ID 63187-466_387169e5-fdc7-4bd8-94f5-ce71571dd90e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040401
Listing Expiration 2026-12-31
Marketing Start 2003-02-27

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 63187466
Hyphenated Format 63187-466

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 ANDA040401 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (63187-466-64) / 240 mL in 1 BOTTLE
source: ndc

Packages (1)

63187-466-64 1 BOTTLE in 1 CARTON (63187-466-64) / 240 mL in 1 BOTTLE

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": "387169e5-fdc7-4bd8-94f5-ce71571dd90e", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["9PHQ9Y1OLM"], "rxcui": ["283077"], "spl_set_id": ["246703b1-a792-4653-a391-02d3c6212cb7"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (63187-466-64)  / 240 mL in 1 BOTTLE", "package_ndc": "63187-466-64", "marketing_start_date": "20190101"}], "brand_name": "Prednisolone", "product_id": "63187-466_387169e5-fdc7-4bd8-94f5-ce71571dd90e", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "63187-466", "generic_name": "Prednisolone", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prednisolone", "active_ingredients": [{"name": "PREDNISOLONE", "strength": "15 mg/5mL"}], "application_number": "ANDA040401", "marketing_category": "ANDA", "marketing_start_date": "20030227", "listing_expiration_date": "20261231"}