FDA.reportPublic FDA data

Glipizide

Product NDC
33261-397
11-digit product format
332610397
Labeler code
33261
Product ID
33261-397_c5e4b51a-8b09-4030-8221-7de9183d4110
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA075795
Marketing category
ANDA
Marketing start
2002-09-25
Marketing end
0000-00-00
Substance
GLIPIZIDE
Active strength
5 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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
33261-397-302020-01-31C16284748780-19d75b9d0-1ddd-f424-e053-dadaa90a57ceGLIPIZIDE TABLETS, USP 5 mg and 10 mg Rx Only
33261-397-602020-01-31C16284748780-19d75b9d0-1ddd-f424-e053-dadaa90a57ceGLIPIZIDE TABLETS, USP 5 mg and 10 mg Rx Only
33261-397-902020-01-31C16284748780-19d75b9d0-1ddd-f424-e053-dadaa90a57ceGLIPIZIDE TABLETS, USP 5 mg and 10 mg Rx Only
33261-397-992020-01-31C16284748780-19d75b9d0-1ddd-f424-e053-dadaa90a57ceGLIPIZIDE TABLETS, USP 5 mg and 10 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-397-30Glipizide30 in 1 BOTTLE, PLASTICTABLET301
33261-397-60Glipizide60 in 1 BOTTLE, PLASTICTABLET601
33261-397-90Glipizide90 in 1 BOTTLE, PLASTICTABLET901
33261-397-99Glipizide180 in 1 BOTTLE, PLASTICTABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-397-30EA - Each33261-39775420260-4590-46b1-9ce7-c1477aeefbb812015-10-02
33261-397-60EA - Each33261-3977f97d134-10ad-43c8-a69d-8268dc5d8b6512015-10-02
33261-397-90EA - Each33261-39768c5f291-46f6-4850-8ae2-bbea8c669ac612015-10-02
33261-397-99EA - Each33261-397418668cf-3827-4394-9541-481689dabfd912016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIPIZIDEACTIVE INGREDIENTX7WDT95N5CGLIPIZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
GLIPIZIDEACTIVE MOIETYX7WDT95N5CGLIPIZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKGLIPIZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIPIZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GLIPIZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIPIZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-397GLIPIZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20140110_f2e596df-81f9-4c59-8dd6-580c5c2ad7c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310488glipiZIDE 10 MG Oral TabletPSNf2e596df-81f9-4c59-8dd6-580c5c2ad7c81
310490glipiZIDE 5 MG Oral TabletPSNf2e596df-81f9-4c59-8dd6-580c5c2ad7c81
310488glipizide 10 MG Oral TabletSCDf2e596df-81f9-4c59-8dd6-580c5c2ad7c81
310490glipizide 5 MG Oral TabletSCDf2e596df-81f9-4c59-8dd6-580c5c2ad7c81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-397-303326103973030 in 1 BOTTLE, PLASTICHistorical
33261-397-603326103976060 in 1 BOTTLE, PLASTICHistorical
33261-397-903326103979090 in 1 BOTTLE, PLASTICHistorical
33261-397-9933261039799180 in 1 BOTTLE, PLASTICHistorical