sulfADIAZINE

Product NDC
62135-842
11-digit product format
621350842
Labeler code
62135
Product ID
62135-842_22e33608-9604-ec44-e063-6394a90a3d12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfADIAZINE
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA080084
Marketing category
ANDA
Marketing start
2024-09-23
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
62135-842-60sulfADIAZINE60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-842-60EA - Each62135-8424db819ec-b983-475e-a0c1-45f470124c9e12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-842SULFADIAZINE TABLET [CHARTWELL RX, LLC]1Current NDC, 1 package rows20240926_6032d6f7-cbce-4e5d-841c-a1e24b616f91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198228sulfADIAZINE 500 MG Oral TabletPSN6032d6f7-cbce-4e5d-841c-a1e24b616f911
198228sulfadiazine 500 MG Oral TabletSCD6032d6f7-cbce-4e5d-841c-a1e24b616f911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-842-606213508426060 TABLET in 1 BOTTLE (62135-842-60) 60 tablet2024-09-23NoNoHistorical