SULFADIAZINE

Product NDC
42806-757
11-digit product format
428060757
Labeler code
42806
Product ID
42806-757_69f2d77c-8279-4524-93c2-f199e7973400
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfadiazine
Dosage form
TABLET
Route
ORAL
Labeler
EPIC PHARMA, LLC
Application
ANDA040091
Marketing category
ANDA
Marketing start
2021-12-15
Substance
SULFADIAZINE
Active strength
500 mg/1
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFADIAZINE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0N7609K889
Rxcui198228

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
52d15095-bb55-0cfb-f7b0-5be5a913b7dbProduct name120140508
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-757-60SULFADIAZINE60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-757-60EA - Each42806-757f4dd1eac-7dfb-44ba-94d2-04ddea5f7ec712022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-757SULFADIAZINE TABLET [EPIC PHARMA, LLC]2Current NDC, Legacy NDC, 1 package rows20231221_8993651b-fff6-4e3f-9b60-78587bc9bcee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198228sulfADIAZINE 500 MG Oral TabletPSN8993651b-fff6-4e3f-9b60-78587bc9bcee2
198228sulfadiazine 500 MG Oral TabletSCD8993651b-fff6-4e3f-9b60-78587bc9bcee2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-757-604280607576060 TABLET in 1 BOTTLE (42806-757-60) 60 tablet2021-12-150000-00-00NoNoCurrent