prednisolone

Generic: prednisolone

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prednisolone
Generic Name prednisolone
Labeler pai holdings, llc dba pai pharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

prednisolone 15 mg/5mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-0885
Product ID 0121-0885_1166b85b-73c5-4a8f-bc41-f99b406d0ff5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040571
Listing Expiration 2026-12-31
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 01210885
Hyphenated Format 0121-0885

Supplemental Identifiers

RxCUI
283077
UPC
0301210885082
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 ANDA040571 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/5mL
source: ndc
Packaging
  • 240 mL in 1 BOTTLE (0121-0885-08)
  • 480 mL in 1 BOTTLE (0121-0885-16)
source: ndc

Packages (2)

0121-0885-08 240 mL in 1 BOTTLE (0121-0885-08) 0121-0885-16 480 mL in 1 BOTTLE (0121-0885-16)

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": "1166b85b-73c5-4a8f-bc41-f99b406d0ff5", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0301210885082"], "unii": ["9PHQ9Y1OLM"], "rxcui": ["283077"], "spl_set_id": ["cebd7b5b-8e9f-4de9-9fcf-8ee0661fede3"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "240 mL in 1 BOTTLE (0121-0885-08)", "package_ndc": "0121-0885-08", "marketing_start_date": "20230912"}, {"sample": false, "description": "480 mL in 1 BOTTLE (0121-0885-16)", "package_ndc": "0121-0885-16", "marketing_start_date": "20230912"}], "brand_name": "Prednisolone", "product_id": "0121-0885_1166b85b-73c5-4a8f-bc41-f99b406d0ff5", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0121-0885", "generic_name": "Prednisolone", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "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": "20261231"}