Glipizide

Product NDC
66336-269
11-digit product format
663360269
Labeler code
66336
Product ID
66336-269_4bbb1030-1e27-4761-9414-2a1f3384894a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA076467
Marketing category
ANDA
Marketing start
2003-11-01
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
66336-269-902019-11-27C16284748780-19855d018-ea2c-cd31-e053-dbdaa90ab51aGlipizide Extended-Release Tablets Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-269-90GlipizideER90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE904

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIPIZIDEACTIVE INGREDIENTX7WDT95N5CGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
GLIPIZIDEACTIVE MOIETYX7WDT95N5CGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
ACETYLTRIBUTYL CITRATEINACTIVE INGREDIENT0ZBX0N59RZGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
AMMONIAINACTIVE INGREDIENT5138Q19F1XGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN16GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
POLYETHYLENE GLYCOLsINACTIVE INGREDIENT3WJQ0SDW1AGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4
SHELLACINACTIVE INGREDIENT46N107B71OGLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-269GLIPIZIDE ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]4Legacy NDC, 1 package rows20121002_69a77643-d1db-4fd2-a2cc-1c003422757f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-269-906633602699090 in 1 BOTTLEHistorical