prednisolone

Generic: prednisolone

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

Drug Facts

Product Profile

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

prednisolone 5 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-437
Product ID 62135-437_1b180b1a-f4e2-e1ee-e063-6294a90adc05
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080531
Listing Expiration 2026-12-31
Marketing Start 1974-05-31

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 62135437
Hyphenated Format 62135-437

Supplemental Identifiers

RxCUI
198142
UPC
0362135437305
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 ANDA080531 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (62135-437-30)
source: ndc

Packages (1)

62135-437-30 30 TABLET in 1 BOTTLE (62135-437-30)

Ingredients (1)

prednisolone (5 mg/1)

Linked Drug Pages (1)

Prednisolone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1b180b1a-f4e2-e1ee-e063-6294a90adc05", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0362135437305"], "unii": ["9PHQ9Y1OLM"], "rxcui": ["198142"], "spl_set_id": ["2e965355-f7f2-4dd3-9c5c-1524c6f39c91"], "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": "30 TABLET in 1 BOTTLE (62135-437-30)", "package_ndc": "62135-437-30", "marketing_start_date": "20230308"}], "brand_name": "Prednisolone", "product_id": "62135-437_1b180b1a-f4e2-e1ee-e063-6294a90adc05", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "62135-437", "generic_name": "Prednisolone", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prednisolone", "active_ingredients": [{"name": "PREDNISOLONE", "strength": "5 mg/1"}], "application_number": "ANDA080531", "marketing_category": "ANDA", "marketing_start_date": "19740531", "listing_expiration_date": "20261231"}