prednisolone

Generic: prednisolone oral

Labeler: chartwell governmental & specialty rx, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

prednisolone 15 mg/5mL

Manufacturer
Chartwell Governmental & Specialty RX, LLC.

Identifiers & Regulatory

Product NDC 68999-250
Product ID 68999-250_43e3bba6-a836-f5e7-e063-6294a90a10e4
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 68999250
Hyphenated Format 68999-250

Supplemental Identifiers

RxCUI
283077
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 (68999-250-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-250-45)
source: ndc

Packages (1)

68999-250-24 2 TRAY in 1 BOX (68999-250-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-250-45)

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": "43e3bba6-a836-f5e7-e063-6294a90a10e4", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["9PHQ9Y1OLM"], "rxcui": ["283077"], "spl_set_id": ["2dac9898-6492-4f34-ad86-83a902e0fe0b"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Chartwell Governmental & Specialty RX, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (68999-250-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-250-45)", "package_ndc": "68999-250-24", "marketing_start_date": "20251114"}], "brand_name": "Prednisolone", "product_id": "68999-250_43e3bba6-a836-f5e7-e063-6294a90a10e4", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68999-250", "generic_name": "Prednisolone oral", "labeler_name": "Chartwell Governmental & Specialty 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"}