Erythromycin

Product NDC
52565-033
11-digit product format
525650033
Labeler code
52565
Product ID
52565-033_f025369b-bbc2-4856-8fbb-19efd5aafbe3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
GEL
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA208154
Marketing category
ANDA
Marketing start
2017-07-26
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 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
52565-033-302023-01-30C16284748780-1f386c649-fd9e-0266-e053-dadaa90a7c1aErythromycin Topical Gel USP, 2%
52565-033-602023-01-30C16284748780-1f386c649-fd9e-0266-e053-dadaa90a7c1aErythromycin Topical Gel USP, 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-033-30Erythromycin1 in 1 CARTONGEL13
52565-033-30Erythromycin30 g in 1 TUBEGEL303
52565-033-60Erythromycin60 g in 1 TUBEGEL603
52565-033-60Erythromycin1 in 1 CARTONGEL13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-033-30GM - Gram52565-03368f6c3b0-4906-47a4-bdc3-604e4d0548ee12017-10-13
52565-033-60GM - Gram52565-0335b447f9c-d3ad-418b-8e7c-08c1f0ec909f12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-033ERYTHROMYCIN (ERYTHROMYCIN) GEL [TELIGENT PHARMA, INC.]3Legacy NDC, 4 package rows20191109_b21d02ea-5394-4f88-8d2b-3a8cd6e807a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310152erythromycin 2 % Topical GelPSNb21d02ea-5394-4f88-8d2b-3a8cd6e807a03
310152erythromycin 0.02 MG/MG Topical GelSCDb21d02ea-5394-4f88-8d2b-3a8cd6e807a03
310152erythromycin 2 % Topical GelSYb21d02ea-5394-4f88-8d2b-3a8cd6e807a03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-033-30525650033301 TUBE in 1 CARTON (52565-033-30) > 30 g in 1 TUBE1 tube2017-07-260000-00-00NoNoCurrent
52565-033-60525650033601 TUBE in 1 CARTON (52565-033-60) > 60 g in 1 TUBE1 tube2017-07-260000-00-00NoNoCurrent