GlipizideER

Product NDC
33261-835
11-digit product format
332610835
Labeler code
33261
Product ID
33261-835_3d03c9eb-c4a2-4d2c-9be3-3c18753096ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076467
Marketing category
ANDA
Marketing start
2003-11-07
Marketing end
0000-00-00
Substance
GLIPIZIDE
Active strength
10 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
33261-835-302020-01-31C16284748780-19d75b9d0-a21c-f424-e053-dadaa90a57ceGlipizide Extended-Release Tablets Revised: January 2013 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-835-30GlipizideERER30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-835-30EA - Each33261-835f439724c-e04f-4d85-a486-37a02a73821412015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIPIZIDEACTIVE INGREDIENTX7WDT95N5CGLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
GLIPIZIDEACTIVE MOIETYX7WDT95N5CGLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
ACETYLTRIBUTYL CITRATEINACTIVE INGREDIENT0ZBX0N59RZGLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XGLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN16GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PGLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OGLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-835GLIPIZIDEER ER (GLIPIZIDE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140110_6c92a536-508d-4e94-89af-453e3eb2a560.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN6c92a536-508d-4e94-89af-453e3eb2a5601
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSN6c92a536-508d-4e94-89af-453e3eb2a5601
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD6c92a536-508d-4e94-89af-453e3eb2a5601
31400624 HR glipizide 5 MG Extended Release Oral TabletSCD6c92a536-508d-4e94-89af-453e3eb2a5601
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY6c92a536-508d-4e94-89af-453e3eb2a5601
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSY6c92a536-508d-4e94-89af-453e3eb2a5601
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY6c92a536-508d-4e94-89af-453e3eb2a5601
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSY6c92a536-508d-4e94-89af-453e3eb2a5601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-835-303326108353030 in 1 BOTTLE, PLASTICHistorical