FDA.reportPublic FDA data

erythromycin topical solution 2%

Product NDC
71656-030
11-digit product format
716560030
Labeler code
71656
Product ID
71656-030_21b6729d-f82f-309a-e063-6394a90a8a36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
erythromycin topical solution 2%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Saptalis Pharmaceuticals, LLC LLC
Application
ANDA062687
Marketing category
ANDA
Marketing start
2024-08-14
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 topical solution 2%
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
8c898317-b543-1e4e-254f-84cec2f3f57eProduct name220191002
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
64ae94c0-3212-d73a-92da-9e6dd85c6ebeProduct name220180118
edcfa1cf-915f-1a4c-d0aa-508cc66e70d9Product name220170816
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
71656-030-60erythromycin topical solution 2%1 in 1 CARTONSOLUTION12
71656-030-60erythromycin topical solution 2%60 mL in 1 BOTTLESOLUTION602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71656-030-60ML - Milliliter71656-030e7516eec-e6c7-4e7d-8e4c-90d0fe7aa6d612024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71656-030ERYTHROMYCIN TOPICAL SOLUTION 2% SOLUTION [SAPTALIS PHARMACEUTICALS, LLC LLC]2Current NDC, 2 package rows20240910_21b64a3f-2c95-1c1a-e063-6294a90a0ea0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
318202erythromycin 2 % Topical SolutionPSN21b64a3f-2c95-1c1a-e063-6294a90a0ea02
318202erythromycin 20 MG/ML Topical SolutionSCD21b64a3f-2c95-1c1a-e063-6294a90a0ea02
318202erythromycin 2 % Topical SolutionSY21b64a3f-2c95-1c1a-e063-6294a90a0ea02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71656-030-60716560030601 BOTTLE in 1 CARTON (71656-030-60) / 60 mL in 1 BOTTLE1 bottle2024-08-14NoNoHistorical