FDA.reportPublic FDA data

Erythromycin

Product NDC
53217-021
11-digit product format
532170021
Labeler code
53217
Product ID
53217-021_c7176ee9-dfa5-47e9-b972-17c2273a81ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
GEL
Route
TOPICAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA063211
Marketing category
ANDA
Marketing start
2008-06-12
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
2019-12-31
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
53217-021-012020-01-31C16284748780-19d75b9cf-f212-f424-e053-dadaa90a57ceErythromycin Topical Gel USP, 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-021-01Erythromycin60 g in 1 TUBEGEL601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-021-01GM - Gram53217-021a5ec8ad6-7492-4c2a-bb0d-6abb1ae3e0bd12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ERYTHROMYCINACTIVE INGREDIENT63937KV33DERYTHROMYCIN GEL [AIDAREX PHARMACEUTICALS LLC]1
ERYTHROMYCINACTIVE MOIETY63937KV33DERYTHROMYCIN GEL [AIDAREX PHARMACEUTICALS LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MERYTHROMYCIN GEL [AIDAREX PHARMACEUTICALS LLC]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PERYTHROMYCIN GEL [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-021ERYTHROMYCIN GEL [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140214_75ad87b8-b384-4fad-9193-39b70c300168.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310152erythromycin 2 % Topical GelPSN75ad87b8-b384-4fad-9193-39b70c3001681
310152erythromycin 0.02 MG/MG Topical GelSCD75ad87b8-b384-4fad-9193-39b70c3001681
310152erythromycin 2 % Topical GelSY75ad87b8-b384-4fad-9193-39b70c3001681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53217-021-015321700210160 g in 1 TUBE60 gHistorical