Erythrocin Stearate
ERYTHROCIN STEARATE ERYTHROMYCIN STEARATE TABLETS, USP
Approved
Approval ID
6c789378-0ec7-4874-aa42-e3418e859f86
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 2018
Manufacturers
FDA
Arbor Pharmaceuticals, Inc.
DUNS: 781796417
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ERYTHROMYCIN STEARATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-106
Application NumberANDA060359
Product Classification
M
Marketing Category
C73584
G
Generic Name
ERYTHROMYCIN STEARATE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 4, 2018
FDA Product Classification
INGREDIENTS (13)
powdered celluloseInactive
Code: SMD1X3XO9M
Classification: IACT
polacrilin potassiumInactive
Code: 0BZ5A00FQU
Classification: IACT
D&C Red No. 7Inactive
Code: ECW0LZ41X8
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ERYTHROMYCIN STEARATEActive
Quantity: 250 mg in 1 1
Code: LXW024X05M
Classification: ACTIM
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
sorbic acidInactive
Code: X045WJ989B
Classification: IACT
sorbitan monooleateInactive
Code: 06XEA2VD56
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 12/4/2018
EST-PI-03 Revised: October 2018
Arbor Pharmaceuticals, LLC
Atlanta, GA 30328 USA
(No. 6346)