Proglycem

Product NDC
0575-6200
11-digit product format
005756200
Labeler code
0575
Product ID
0575-6200_451aa56d-e2e5-402f-843a-cddb5b3d37dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diazoxide
Dosage form
SUSPENSION
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
NDA017453
Marketing category
NDA
Marketing start
1990-09-30
Substance
DIAZOXIDE
Active strength
50 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIAZOXIDE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO5CB12L4FN
Rxcui197593, 207634

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9a8e650a-7aae-491c-b4cb-53c9bf46f42dProduct name120260112
dca952e2-dead-7d30-59c8-ab2d6e0c38a2Product name320210127

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0575-6200-30Proglycem30 mL in 1 BOTTLE, DROPPERSUSPENSION3015
0575-6200-30Proglycem1 in 1 BOXSUSPENSION115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0575-6200-30ML - Milliliter0575-6200fbc1bbbb-2ced-4c3c-8589-e9c0dd61a83712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIAZOXIDEACTIVE INGREDIENTO5CB12L4FNPROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]5
DIAZOXIDEACTIVE MOIETYO5CB12L4FNPROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]5
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311PROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]5
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]5
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCPROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]5
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGPROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]5
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]5
SORBITOLINACTIVE INGREDIENT506T60A25RPROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RPROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0575-6200PROGLYCEM (DIAZOXIDE) SUSPENSION [TEVA PHARMACEUTICALS USA, INC.]15Current NDC, Legacy NDC, 2 package rows20240723_b16c7832-2fd9-49af-b923-1dc0d91fd6e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197593diazoxide 50 MG in 1 mL Oral SuspensionPSNb16c7832-2fd9-49af-b923-1dc0d91fd6e215
207634Proglycem 50 MG in 1 mL Oral SuspensionPSNb16c7832-2fd9-49af-b923-1dc0d91fd6e215
207634diazoxide 50 MG/ML Oral Suspension [Proglycem]SBDb16c7832-2fd9-49af-b923-1dc0d91fd6e215
197593diazoxide 50 MG/ML Oral SuspensionSCDb16c7832-2fd9-49af-b923-1dc0d91fd6e215
197593diazoxide 50 MG per 1 ML Oral SuspensionSYb16c7832-2fd9-49af-b923-1dc0d91fd6e215
207634Proglycem 50 MG per 1 ML Oral SuspensionSYb16c7832-2fd9-49af-b923-1dc0d91fd6e215

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0575-6200-30005756200301 BOTTLE, DROPPER in 1 BOX (0575-6200-30) / 30 mL in 1 BOTTLE, DROPPER1990-09-300000-00-00NoNoCurrent