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FDA Approval

Hydrocortisone

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Chartwell RX, LLC.
DUNS: 079394054
Effective Date
March 21, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Hydrocortisone(5 mg in 1 1)

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Hydrocortisone

Product Details

NDC Product Code
62135-551
Application Number
ANDA207029
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 21, 2023
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Code: WI4X0X7BPJClass: ACTIBQuantity: 5 mg in 1 1

Hydrocortisone

Product Details

NDC Product Code
62135-552
Application Number
ANDA207029
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 21, 2023
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: WI4X0X7BPJClass: ACTIBQuantity: 10 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
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