ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL

Product NDC
21695-690
11-digit product format
216950690
Labeler code
21695
Product ID
21695-690_60d1aea0-f106-4b20-8ef4-7a80e37f8a50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL
Dosage form
GRANULE, FOR SUSPENSION
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA062759
Marketing category
ANDA
Marketing start
1988-05-20
Marketing end
0000-00-00
Substance
ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL
Active strength
200 mg/5mL; mg/5mL
Pharmacologic classes
Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
21695-690-002019-09-24C16284748780-1934fe258-475b-48b1-e053-8cdaa90a720aERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL FOR ORAL SUSPENSION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-690-00ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL100 mL in 1 BOTTLEGRANULE, FOR SUSPENSION1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-690-00ML - Milliliter21695-6908b0bcfd2-5efc-4639-aa88-bd326c8a311612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ERYTHROMYCIN ETHYLSUCCINATEACTIVE INGREDIENT1014KSJ86FERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL GRANULE, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
SULFISOXAZOLE ACETYLACTIVE INGREDIENTWBT5QH3KEDERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL GRANULE, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
ERYTHROMYCINACTIVE MOIETY63937KV33DERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL GRANULE, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
SULFISOXAZOLEACTIVE MOIETY740T4C525WERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL GRANULE, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
ANHYDROUS TRISODIUM CITRATEINACTIVE INGREDIENTRS7A450LGAERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL GRANULE, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
LACTOSE, ANHYDROUSINACTIVE INGREDIENT3SY5LH9PMKERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL GRANULE, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL GRANULE, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL GRANULE, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL GRANULE, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
SUCROSEINACTIVE INGREDIENTC151H8M554ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL GRANULE, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-690ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL GRANULE, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110121_60d1aea0-f106-4b20-8ef4-7a80e37f8a50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686383erythromycin ethylsuccinate 200 MG / sulfiSOXAZOLE 600 MG in 5 mL Oral SuspensionPSN60d1aea0-f106-4b20-8ef4-7a80e37f8a501
686383erythromycin ethylsuccinate 40 MG/ML / sulfisoxazole 120 MG/ML Oral SuspensionSCD60d1aea0-f106-4b20-8ef4-7a80e37f8a501
686383EES 40 MG/ML / Sulfisoxazole 120 MG/ML Oral SuspensionSY60d1aea0-f106-4b20-8ef4-7a80e37f8a501
686383erythromycin ethylsuccinate 200 MG / sulfisoxazole 600 MG per 5 ML Oral SuspensionSY60d1aea0-f106-4b20-8ef4-7a80e37f8a501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-690-0021695069000100 mL in 1 BOTTLE100 mlHistorical