FDA.reportPublic FDA data

Glipizide

Product NDC
71335-9742
11-digit product format
713359742
Labeler code
71335
Product ID
71335-9742_2296f3d7-83d8-40b9-b0b4-375847fb9cf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206928
Marketing category
ANDA
Marketing start
2023-03-03
Substance
GLIPIZIDE
Active strength
5 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Glipizide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIPIZIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX7WDT95N5C
Rxcui314006

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
71335-9742-1Glipizide90 in 1 BOTTLETABLET, EXTENDED RELEASE90101
71335-9742-2Glipizide30 in 1 BOTTLETABLET, EXTENDED RELEASE30101
71335-9742-3Glipizide60 in 1 BOTTLETABLET, EXTENDED RELEASE60101
71335-9742-4Glipizide100 in 1 BOTTLETABLET, EXTENDED RELEASE100101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9742GLIPIZIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]100Current NDC, 4 package rows20230711_4afa67b2-7f86-4189-93a5-6a605f74540d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSN4afa67b2-7f86-4189-93a5-6a605f74540d101
31400624 HR glipizide 5 MG Extended Release Oral TabletSCD4afa67b2-7f86-4189-93a5-6a605f74540d101
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSY4afa67b2-7f86-4189-93a5-6a605f74540d101
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSY4afa67b2-7f86-4189-93a5-6a605f74540d101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9742-17133597420190 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9742-1) 2026-04-09NoNoHistorical
71335-9742-27133597420230 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9742-2) 2023-06-26NoNoHistorical
71335-9742-37133597420360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9742-3) 2026-04-09NoNoHistorical
71335-9742-471335974204100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9742-4) 2023-07-14NoNoHistorical