Erythromycin

Product NDC
13985-605
11-digit product format
139850605
Labeler code
13985
Product ID
13985-605_835007c4-823c-4325-ba5f-ad25eb46be54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
MWI
Application
ANDA064030
Marketing category
ANDA
Marketing start
2015-03-23
Marketing end
0000-00-00
Substance
ERYTHROMYCIN
Active strength
5 mg/g
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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d329c2e1-5ae8-4e64-aea0-77ecea3fa1abProduct name320250717
3b331500-3b74-bd2b-fede-d46839f2f4d5Product name620240313
fdae2630-eae0-4769-abfd-8f33d5b771b4Product name320240202
8c898317-b543-1e4e-254f-84cec2f3f57eProduct name220191002
64ae94c0-3212-d73a-92da-9e6dd85c6ebeProduct name220180118
edcfa1cf-915f-1a4c-d0aa-508cc66e70d9Product name220170816
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
57850177-5927-151f-e1fa-7e2ca47f81e5Product name120140508
8ee71591-1d8f-e24e-242b-bfef131e3168Product name120140508
bff5cf99-0f45-fa15-2a76-b160c3c4cc3cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13985-605-032024-01-30C16284748780-11030e365-4c10-111a-e063-dadaa90a10e2apexa™ Erythromycin Ophthalmic Ointment USP, 0.5% STERILE Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13985-605-03Erythromycin1 in 1 CARTONOINTMENT14
13985-605-03Erythromycin3.5 g in 1 TUBEOINTMENT3.54

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ErythromycinACTIVE INGREDIENT63937KV33DERYTHROMYCIN OINTMENT [MWI]1
ErythromycinACTIVE MOIETY63937KV33DERYTHROMYCIN OINTMENT [MWI]1
Mineral OilINACTIVE INGREDIENTT5L8T28FGPERYTHROMYCIN OINTMENT [MWI]1
PetrolatumINACTIVE INGREDIENT4T6H12BN9UERYTHROMYCIN OINTMENT [MWI]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13985-605ERYTHROMYCIN OINTMENT [MWI]4Legacy NDC, 2 package rows20220127_407ff426-4cca-4b65-b2d3-eb2f078bfa39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310149erythromycin 0.5 % (5 MG/GM) Ophthalmic OintmentPSN407ff426-4cca-4b65-b2d3-eb2f078bfa394
310149erythromycin 0.005 MG/MG Ophthalmic OintmentSCD407ff426-4cca-4b65-b2d3-eb2f078bfa394
310149erythromycin 0.5 % Ophthalmic OintmentSY407ff426-4cca-4b65-b2d3-eb2f078bfa394
310149erythromycin 5 MG per GM Ophthalmic OintmentSY407ff426-4cca-4b65-b2d3-eb2f078bfa394

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13985-605-03139850605031 TUBE in 1 CARTON (13985-605-03) > 3.5 g in 1 TUBE1 tube2015-03-230000-00-00NoNoCurrent