FDA.reportPublic FDA data

Glipizide

Product NDC
63629-1398
11-digit product format
636291398
Labeler code
63629
Product ID
63629-1398_2f412bc4-8fc2-4d9b-80f6-89eb15ae42e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074223
Marketing category
ANDA
Marketing start
1995-02-27
Substance
GLIPIZIDE
Active strength
5 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIPIZIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX7WDT95N5C
Rxcui310490

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1398-1Glipizide100 in 1 BOTTLETABLET1001016
63629-1398-2Glipizide30 in 1 BOTTLETABLET301016
63629-1398-3Glipizide60 in 1 BOTTLETABLET601016
63629-1398-4Glipizide90 in 1 BOTTLETABLET901016
63629-1398-5Glipizide20 in 1 BOTTLETABLET201016
63629-1398-6Glipizide180 in 1 BOTTLETABLET1801016
63629-1398-7Glipizide10 in 1 BOTTLETABLET101016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1398-1EA - Each63629-13987f553fd4-a89f-4aa7-a789-009d2b6cc11d12014-08-01
63629-1398-2EA - Each63629-1398b062b8d6-f05f-45fa-b962-ee84dc2e77ac12014-08-01
63629-1398-3EA - Each63629-139870240fbf-b071-430c-b8c1-6a6802fdb2b012014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIPIZIDEACTIVE INGREDIENTX7WDT95N5CGLIPIZIDE TABLET [BRYANT RANCH PREPACK]1000
GLIPIZIDEACTIVE MOIETYX7WDT95N5CGLIPIZIDE TABLET [BRYANT RANCH PREPACK]1000
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKGLIPIZIDE TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIPIZIDE TABLET [BRYANT RANCH PREPACK]1000
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GLIPIZIDE TABLET [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GLIPIZIDE TABLET [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGLIPIZIDE TABLET [BRYANT RANCH PREPACK]1000
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGLIPIZIDE TABLET [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1398GLIPIZIDE TABLET [BRYANT RANCH PREPACK]1016Current NDC, Legacy NDC, 7 package rows20240828_afb65cc1-a4fb-4771-b09c-dcf6e8c5786e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310490glipiZIDE 5 MG Oral TabletPSNafb65cc1-a4fb-4771-b09c-dcf6e8c5786e1016
310490glipizide 5 MG Oral TabletSCDafb65cc1-a4fb-4771-b09c-dcf6e8c5786e1016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1398-163629139801100 TABLET in 1 BOTTLE (63629-1398-1) 100 tablet2006-02-070000-00-00NoNoCurrent
63629-1398-26362913980230 TABLET in 1 BOTTLE (63629-1398-2) 30 tablet2004-12-200000-00-00NoNoCurrent
63629-1398-36362913980360 TABLET in 1 BOTTLE (63629-1398-3) 60 tablet2004-12-140000-00-00NoNoCurrent
63629-1398-46362913980490 TABLET in 1 BOTTLE (63629-1398-4) 90 tablet2012-08-020000-00-00NoNoCurrent
63629-1398-56362913980520 TABLET in 1 BOTTLE (63629-1398-5) 20 tablet2022-04-290000-00-00NoNoCurrent
63629-1398-663629139806180 TABLET in 1 BOTTLE (63629-1398-6) 180 tablet2015-05-150000-00-00NoNoCurrent
63629-1398-76362913980710 TABLET in 1 BOTTLE (63629-1398-7) 10 tablet2022-04-290000-00-00NoNoCurrent