FDA.reportPublic FDA data

erythromycin

Product NDC
45802-038
11-digit product format
458020038
Labeler code
45802
Product ID
45802-038_81c83ddb-5432-484c-8a60-e51677a62c6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
erythromycin
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA063038
Marketing category
ANDA
Marketing start
2011-12-19
Substance
ERYTHROMYCIN
Active strength
20 mg/mL
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
erythromycin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERYTHROMYCIN20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii63937KV33D
Rxcui318202

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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-038-46erythromycin60 mL in 1 BOTTLESOLUTION6011
45802-038-46erythromycin1 in 1 CARTONSOLUTION111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-038-46ML - Milliliter45802-0385b48f6c5-4aa6-4d48-af40-40e3bc0be0ed12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ERYTHROMYCINACTIVE INGREDIENT63937KV33DERYTHROMYCIN SOLUTION [PERRIGO NEW YORK INC]4
ERYTHROMYCINACTIVE MOIETY63937KV33DERYTHROMYCIN SOLUTION [PERRIGO NEW YORK INC]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MERYTHROMYCIN SOLUTION [PERRIGO NEW YORK INC]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPERYTHROMYCIN SOLUTION [PERRIGO NEW YORK INC]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ERYTHROMYCIN SOLUTION [PERRIGO NEW YORK INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-038ERYTHROMYCIN SOLUTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]10Current NDC, Legacy NDC, 2 package rows20220828_40edf1bd-42bb-4662-aff6-01fcc133c05d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
318202erythromycin 2 % Topical SolutionPSN00c4f27e-59e2-4173-99b1-59dd295e83de101
318202erythromycin 20 MG/ML Topical SolutionSCD00c4f27e-59e2-4173-99b1-59dd295e83de101
318202erythromycin 2 % Topical SolutionSY00c4f27e-59e2-4173-99b1-59dd295e83de101
318202erythromycin 2 % Topical SolutionPSN40edf1bd-42bb-4662-aff6-01fcc133c05d11
318202erythromycin 20 MG/ML Topical SolutionSCD40edf1bd-42bb-4662-aff6-01fcc133c05d11
318202erythromycin 2 % Topical SolutionSY40edf1bd-42bb-4662-aff6-01fcc133c05d11
318202erythromycin 2 % Topical SolutionPSN8349b4ec-3ca6-bdb6-e053-2a91aa0a8b634
318202erythromycin 20 MG/ML Topical SolutionSCD8349b4ec-3ca6-bdb6-e053-2a91aa0a8b634
318202erythromycin 2 % Topical SolutionSY8349b4ec-3ca6-bdb6-e053-2a91aa0a8b634

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-038-46458020038461 BOTTLE in 1 CARTON (45802-038-46) / 60 mL in 1 BOTTLE1 bottle2011-12-190000-00-00NoNoCurrent