Erythromycin Ethylsuccinate

Product NDC
0254-1021
11-digit product format
002541021
Labeler code
0254
Product ID
0254-1021_8e0eeac7-cbc1-4d20-9f46-893a5f99fc4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin Ethylsuccinate
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA211991
Marketing category
ANDA
Marketing start
2019-11-27
Marketing end
2021-09-30
Substance
ERYTHROMYCIN ETHYLSUCCINATE
Active strength
400 mg/5mL
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0254-1021-47ML - Milliliter0254-1021f1cc94eb-9505-489e-8eab-74395376787d12019-12-10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0254-1021-4700254102147100 mL in 1 BOTTLE (0254-1021-47) 100 ml2019-11-270000-00-00NoNoCurrent