hydrocortisone rectal suspension (retention) (62135-020)

Drug Facts

Product Profile

Brand Name hydrocortisone rectal suspension (retention)

Generic Name hydrocortisone

Labeler chartwell rx llc

Dosage Form SUSPENSION

Routes

RECTAL

Active Ingredients

hydrocortisone 100 mg/60mL

Manufacturer

Chartwell RX LLC

Identifiers & Regulatory

Product NDC 62135-020

Product ID 62135-020_459c2035-71cd-e07e-e063-6394a90a5a3a

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA075172

Listing Expiration 2026-12-31

Marketing Start 1999-12-03

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 62135020

Hyphenated Format 62135-020

Supplemental Identifiers

RxCUI

310878

UPC

0362135020217 0362135020071 0362135020460

UNII

WI4X0X7BPJ

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 hydrocortisone rectal suspension (retention) (source: ndc)

Generic Name hydrocortisone (source: ndc)

Application Number ANDA075172 (source: ndc)

Routes

RECTAL

source: ndc

Resolved Composition

Strengths

100 mg/60mL

source: ndc

Packaging

7 BOTTLE in 1 CARTON (62135-020-07) / 60 mL in 1 BOTTLE
3 CARTON in 1 BOX (62135-020-21) / 7 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE
1 BOTTLE in 1 CARTON (62135-020-46) / 60 mL in 1 BOTTLE

source: ndc

Packages (3)

62135-020-07 7 BOTTLE in 1 CARTON (62135-020-07) / 60 mL in 1 BOTTLE 62135-020-21 3 CARTON in 1 BOX (62135-020-21) / 7 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE 62135-020-46 1 BOTTLE in 1 CARTON (62135-020-46) / 60 mL in 1 BOTTLE

Ingredients (1)

hydrocortisone (100 mg/60mL)

Linked Drug Pages (1)

Hydrocortisone Rectal Suspension (Retention) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["RECTAL"], "spl_id": "459c2035-71cd-e07e-e063-6394a90a5a3a", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0362135020217", "0362135020071", "0362135020460"], "unii": ["WI4X0X7BPJ"], "rxcui": ["310878"], "spl_set_id": ["3fb69485-bfa5-4751-b0ca-a0a0efb6b2b8"], "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": "7 BOTTLE in 1 CARTON (62135-020-07)  / 60 mL in 1 BOTTLE", "package_ndc": "62135-020-07", "marketing_start_date": "20210906"}, {"sample": false, "description": "3 CARTON in 1 BOX (62135-020-21)  / 7 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE", "package_ndc": "62135-020-21", "marketing_start_date": "20211118"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (62135-020-46)  / 60 mL in 1 BOTTLE", "package_ndc": "62135-020-46", "marketing_start_date": "20210906"}], "brand_name": "Hydrocortisone Rectal Suspension (Retention)", "product_id": "62135-020_459c2035-71cd-e07e-e063-6394a90a5a3a", "dosage_form": "SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "62135-020", "generic_name": "Hydrocortisone", "labeler_name": "Chartwell RX LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocortisone Rectal Suspension (Retention)", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "100 mg/60mL"}], "application_number": "ANDA075172", "marketing_category": "ANDA", "marketing_start_date": "19991203", "listing_expiration_date": "20261231"}