Erythromycin

Product NDC
52565-027
11-digit product format
525650027
Labeler code
52565
Product ID
52565-027_414c0043-f201-4fa1-86d3-056bea3ca5bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA208100
Marketing category
ANDA
Marketing start
2017-11-20
Marketing end
0000-00-00
Substance
ERYTHROMYCIN
Active strength
20 mg/mL
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 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
52565-027-592023-01-30C16284748780-1f386c649-df7d-0266-e053-dadaa90a7c1aERYTHROMYCIN TOPICAL SOLUTION USP 2% FOR TOPICAL USE ONLY. NOT FOR USE IN EYES.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-027-59Erythromycin1 in 1 CARTONSOLUTION11
52565-027-59Erythromycin60 mL in 1 BOTTLE, WITH APPLICATORSOLUTION601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-027-59ML - Milliliter52565-02710876a89-b67d-4f3a-8c71-6296f809607d12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-027ERYTHROMYCIN (ERYTHROMYCIN) SOLUTION [TELIGENT PHARMA, INC.]1Legacy NDC, 2 package rows20171121_3ae61263-c0a7-4292-b31f-bbea0893a68e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
318202erythromycin 2 % Topical SolutionPSN3ae61263-c0a7-4292-b31f-bbea0893a68e1
318202erythromycin 20 MG/ML Topical SolutionSCD3ae61263-c0a7-4292-b31f-bbea0893a68e1
318202erythromycin 2 % Topical SolutionSY3ae61263-c0a7-4292-b31f-bbea0893a68e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52565-027-59525650027591 BOTTLE, WITH APPLICATOR in 1 CARTON (52565-027-59) > 60 mL in 1 BOTTLE, WITH APPLICATOR2017-11-200000-00-00NoNoCurrent