prednisolone

Generic: prednisolone oral

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prednisolone
Generic Name prednisolone oral
Labeler chartwell rx, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

prednisolone 15 mg/5mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-250
Product ID 62135-250_19febba3-956f-d1a9-e063-6394a90afda5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040323
Listing Expiration 2026-12-31
Marketing Start 2022-11-20

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 62135250
Hyphenated Format 62135-250

Supplemental Identifiers

RxCUI
283077
UPC
0362135250379 0362135250478
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 oral (source: ndc)
Application Number ANDA040323 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/5mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (62135-250-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-250-45)
  • 240 mL in 1 BOTTLE (62135-250-37)
  • 480 mL in 1 BOTTLE (62135-250-47)
source: ndc

Packages (3)

62135-250-24 2 TRAY in 1 BOX (62135-250-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-250-45) 62135-250-37 240 mL in 1 BOTTLE (62135-250-37) 62135-250-47 480 mL in 1 BOTTLE (62135-250-47)

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": "19febba3-956f-d1a9-e063-6394a90afda5", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0362135250379", "0362135250478"], "unii": ["9PHQ9Y1OLM"], "rxcui": ["283077"], "spl_set_id": ["aa40f582-cced-4e6e-90f0-10ab310ab2a7"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (62135-250-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-250-45)", "package_ndc": "62135-250-24", "marketing_start_date": "20240531"}, {"sample": false, "description": "240 mL in 1 BOTTLE (62135-250-37)", "package_ndc": "62135-250-37", "marketing_start_date": "20221120"}, {"sample": false, "description": "480 mL in 1 BOTTLE (62135-250-47)", "package_ndc": "62135-250-47", "marketing_start_date": "20221120"}], "brand_name": "Prednisolone", "product_id": "62135-250_19febba3-956f-d1a9-e063-6394a90afda5", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "62135-250", "generic_name": "Prednisolone oral", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prednisolone", "active_ingredients": [{"name": "PREDNISOLONE", "strength": "15 mg/5mL"}], "application_number": "ANDA040323", "marketing_category": "ANDA", "marketing_start_date": "20221120", "listing_expiration_date": "20261231"}