Glipizide

Product NDC
53808-0257
11-digit product format
538080257
Labeler code
53808
Product ID
53808-0257_f4c42007-6416-4a89-a0de-5f5fd382d511
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA074497
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
GLIPIZIDE
Active strength
5 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [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
ec4adfb0-aabc-95b9-ad07-5cb8f8533a09Product name220250625
b1de1ca9-d9db-4f4b-2103-09e2014d30d5Product name520180912
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0257-12019-10-21C16284748780-1956f9ecf-ddc4-621f-e053-dbdaa90a74adGLIPIZIDE TABLETS USP For Oral Use Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0257-1Glipizide30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIPIZIDEACTIVE INGREDIENTX7WDT95N5CGLIPIZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GlipizideACTIVE MOIETYX7WDT95N5CGLIPIZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIPIZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIPIZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GLIPIZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGLIPIZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGLIPIZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0257GLIPIZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100614_17d1f383-170e-4e5e-a97e-d346ee026166.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310488glipiZIDE 10 MG Oral TabletPSN17d1f383-170e-4e5e-a97e-d346ee0261661
310490glipiZIDE 5 MG Oral TabletPSN17d1f383-170e-4e5e-a97e-d346ee0261661
310488glipizide 10 MG Oral TabletSCD17d1f383-170e-4e5e-a97e-d346ee0261661
310490glipizide 5 MG Oral TabletSCD17d1f383-170e-4e5e-a97e-d346ee0261661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0257-15380802570130 in 1 BLISTER PACKHistorical