Hydrocortisone Rectal Suspension (Retention)
HYDROCORTISONE RECTAL SUSPENSION, USP (Retention) 100 mg/60 mL DISPOSABLE UNIT FOR RECTAL USE ONLY
Approved
Approval ID
3fb69485-bfa5-4751-b0ca-a0a0efb6b2b8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2022
Manufacturers
FDA
Chartwell RX LLC
DUNS: 079394054
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocortisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-020
Application NumberANDA075172
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocortisone
Product Specifications
Route of AdministrationRECTAL
Effective DateDecember 20, 2022
FDA Product Classification
INGREDIENTS (6)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Inactive
Code: Z135WT9208
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
HYDROCORTISONEActive
Quantity: 100 mg in 60 mL
Code: WI4X0X7BPJ
Classification: ACTIB