prednisolone

Generic: prednisolone

Labeler: redpharm drug, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prednisolone
Generic Name prednisolone
Labeler redpharm drug, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

prednisolone 15 mg/5mL

Manufacturer
RedPharm Drug, Inc.

Identifiers & Regulatory

Product NDC 67296-1656
Product ID 67296-1656_1f3e9f53-9ced-a048-e063-6294a90ae1a3
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 672961656
Hyphenated Format 67296-1656

Supplemental Identifiers

RxCUI
283077
UPC
0367296165661
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
  • 60 mL in 1 BOTTLE (67296-1656-6)
source: ndc

Packages (1)

67296-1656-6 60 mL in 1 BOTTLE (67296-1656-6)

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": "1f3e9f53-9ced-a048-e063-6294a90ae1a3", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0367296165661"], "unii": ["9PHQ9Y1OLM"], "rxcui": ["283077"], "spl_set_id": ["b339a007-6a1e-6578-e053-2995a90a53d0"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["RedPharm Drug, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "60 mL in 1 BOTTLE (67296-1656-6)", "package_ndc": "67296-1656-6", "marketing_start_date": "20030227"}], "brand_name": "Prednisolone", "product_id": "67296-1656_1f3e9f53-9ced-a048-e063-6294a90ae1a3", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "67296-1656", "generic_name": "Prednisolone", "labeler_name": "RedPharm Drug, Inc.", "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"}