Erythromycin

Product NDC
0378-8212
11-digit product format
003788212
Labeler code
0378
Product ID
0378-8212_09b16a2d-825a-4d08-b86e-076548926916
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
erythromycin
Dosage form
GEL
Route
TOPICAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA050617
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-10-19
Marketing end
0000-00-00
Substance
ERYTHROMYCIN
Active strength
20 mg/g
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-8212-60GM - Gram0378-8212f5b3c53d-c231-497b-b572-ceb4901e0a0e12018-11-06
0378-8212-93GM - Gram0378-8212e6ec204c-3bd8-4259-9eff-7cdd41920dcf12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-8212ERYTHROMYCIN GEL [MYLAN PHARMACEUTICALS INC.]2Legacy NDC20250214_09b16a2d-825a-4d08-b86e-076548926916.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-8212-60003788212601 TUBE in 1 CARTON (0378-8212-60) > 60 g in 1 TUBE1 tube2018-10-190000-00-00NoNoCurrent
0378-8212-93003788212931 TUBE in 1 CARTON (0378-8212-93) > 30 g in 1 TUBE1 tube2018-10-190000-00-00NoNoCurrent