Erythromycin Lactobionate

Product NDC
51754-7000
11-digit product format
517547000
Labeler code
51754
Product ID
51754-7000_e69b3024-f4bd-456e-8c74-2f9bc33739c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ERYTHROMYCIN LACTOBIONATE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Exela Pharma Sciences, LLC
Application
ANDA211086
Marketing category
ANDA
Marketing start
2021-03-15
Marketing end
0000-00-00
Substance
ERYTHROMYCIN LACTOBIONATE
Active strength
500 mg/10mL
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51754-7000-32025-12-03C16284748780-12cef2736-79ca-d83d-e063-dadaa90ab31fe69b3024-f4bd-456e-8c74-2f9bc33739c9
51754-7000-32025-01-30C16284748780-12cef2736-79ca-d83d-e063-dadaa90ab31fe69b3024-f4bd-456e-8c74-2f9bc33739c9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51754-7000ERYTHROMYCIN LACTOBIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EXELA PHARMA SCIENCES, LLC]1Legacy NDC20210316_e69b3024-f4bd-456e-8c74-2f9bc33739c9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51754-7000-35175470000310 VIAL, SINGLE-DOSE in 1 PACKAGE (51754-7000-3) > 10 mL in 1 VIAL, SINGLE-DOSE2021-03-150000-00-00NoNoCurrent