FDA.reportPublic FDA data

Erythromycin and Benzoyl Peroxide

Product NDC
64980-328
11-digit product format
649800328
Labeler code
64980
Product ID
64980-328_8547932c-ed72-4e13-b8fe-2b78919399d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin and Benzoyl Peroxide
Dosage form
GEL
Route
TOPICAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA065385
Marketing category
ANDA
Marketing start
2016-10-18
Substance
BENZOYL PEROXIDE; ERYTHROMYCIN
Active strength
50; 30 mg/g; mg/g
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 and Benzoyl Peroxide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE50 mg/g
ERYTHROMYCIN30 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW9WZN9A0GM, 63937KV33D
Rxcui244374

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
d329c2e1-5ae8-4e64-aea0-77ecea3fa1abProduct name320250717
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
3b331500-3b74-bd2b-fede-d46839f2f4d5Product name620240313
fdae2630-eae0-4769-abfd-8f33d5b771b4Product name320240202
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
8c898317-b543-1e4e-254f-84cec2f3f57eProduct name220191002
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
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
64980-328-01Erythromycin and Benzoyl Peroxide23.3 g in 1 JARGEL23.36
64980-328-02Erythromycin and Benzoyl Peroxide46.6 g in 1 JARGEL46.66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-328-01GM - Gram64980-3284d3929dc-589c-4d2f-b65c-4c7a0148b69b12016-11-08
64980-328-02GM - Gram64980-32819c0172f-1007-4af5-986a-5c21248ffc2312016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-328ERYTHROMYCIN AND BENZOYL PEROXIDE GEL [RISING PHARMA HOLDINGS, INC.]5Current NDC, Legacy NDC, 2 package rows20240815_d449d7e2-5c25-406d-87ab-30809d292476.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
244374erythromycin 3 % / benzoyl peroxide 5 % Topical GelPSNd449d7e2-5c25-406d-87ab-30809d2924766
244374benzoyl peroxide 0.05 MG/MG / erythromycin 0.03 MG/MG Topical GelSCDd449d7e2-5c25-406d-87ab-30809d2924766
244374benzoyl peroxide 5 % / erythromycin 3 % Topical GelSYd449d7e2-5c25-406d-87ab-30809d2924766
244374benzoyl peroxide 50 MG / erythromycin 30 MG per GM Topical GelSYd449d7e2-5c25-406d-87ab-30809d2924766

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-328-016498003280123.3 g in 1 JAR (64980-328-01) 23.3 g2016-10-180000-00-00NoNoCurrent
64980-328-026498003280246.6 g in 1 JAR (64980-328-02) 46.6 g2016-10-180000-00-00NoNoCurrent