erythromycin
Erythromycin Delayed-Release Capsules, USP
Approved
Approval ID
16e754a6-f8e0-4ecf-8300-c55aebe73e33
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2022
Manufacturers
FDA
Mayne Pharma Inc.
DUNS: 867220261
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
erythromycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68308-250
Application NumberNDA050536
Product Classification
M
Marketing Category
C73605
G
Generic Name
erythromycin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2022
FDA Product Classification
INGREDIENTS (6)
lactose, unspecified formInactive
Code: J2B2A4N98G
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT
erythromycinActive
Quantity: 250 mg in 1 1
Code: 63937KV33D
Classification: ACTIB
FD&C Yellow NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
gelatin, unspecifiedInactive
Code: 2G86QN327L
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT