ERYGEL

Product NDC
0378-8075
11-digit product format
003788075
Labeler code
0378
Product ID
0378-8075_dce86476-c427-48a9-ad60-e4fe26063028
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
erythromycin
Dosage form
GEL
Route
TOPICAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA050617
Marketing category
NDA
Marketing start
2019-03-07
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
0378-8075-60GM - Gram0378-80752adb05cd-23d5-4247-8f18-1af208cc9a0112019-04-11
0378-8075-93GM - Gram0378-80753ee295d5-20ba-4cb7-b1f2-68ebfde1dc9e12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-8075ERYGEL (ERYTHROMYCIN) GEL [MYLAN PHARMACEUTICALS INC.]3Legacy NDC20250214_f1c6885e-4136-4542-a8a2-7fa8fcd77a03.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-8075-60003788075601 TUBE in 1 CARTON (0378-8075-60) > 60 g in 1 TUBE1 tube2019-03-070000-00-00NoNoCurrent
0378-8075-93003788075931 TUBE in 1 CARTON (0378-8075-93) > 30 g in 1 TUBE1 tube2019-04-110000-00-00NoNoCurrent