Erythromycin Lactobionate

Product NDC
14789-116
11-digit product format
147890116
Labeler code
14789
Product ID
14789-116_c10e5a62-1ef9-47fa-becb-0d6a4f74177b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin Lactobionate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Nexus Pharamaceuticals Inc.
Application
ANDA215290
Marketing category
ANDA
Marketing start
2021-08-01
Marketing end
0000-00-00
Substance
ERYTHROMYCIN LACTOBIONATE
Active strength
500 mg/10mL
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
14789-116-05EA - Each14789-1163532a696-9476-4608-ac4d-8856266840be12022-03-09
14789-116-07EA - Each14789-1169ec06f06-1956-4326-987c-b98f3bbd7a8212022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14789-116ERYTHROMYCIN LACTOBIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NEXUS PHARMACEUTICALS LLC]8Legacy NDC20241017_171b8b28-9da6-4bc6-85ea-f27fde5d5f10.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
14789-116-05147890116055 VIAL, GLASS in 1 BOX (14789-116-05) > 10 mL in 1 VIAL, GLASS (14789-116-07) 2021-08-010000-00-00NoNoCurrent