Glipizide

Product NDC
50090-5806
11-digit product format
500905806
Labeler code
50090
Product ID
50090-5806_50844523-1657-40e7-ba83-320b4b91bc6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204720
Marketing category
ANDA
Marketing start
2017-04-24
Substance
GLIPIZIDE
Active strength
10 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
GLIPIZIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX7WDT95N5C
Rxcui315107

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ec4adfb0-aabc-95b9-ad07-5cb8f8533a09Product name220250625
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
b1de1ca9-d9db-4f4b-2103-09e2014d30d5Product name520180912
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5806-02023-02-07C16284748780-1f386c649-d22c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE extended-release tablets, for oral use Initial U.S. Approval: 1994
50090-5806-12023-02-07C16284748780-1f386c649-d22c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE extended-release tablets, for oral use Initial U.S. Approval: 1994
50090-5806-22023-02-07C16284748780-1f386c649-d22c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE extended-release tablets, for oral use Initial U.S. Approval: 1994
50090-5806-02023-01-30C16284748780-1f386c649-d22c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE extended-release tablets, for oral use Initial U.S. Approval: 1994
50090-5806-12023-01-30C16284748780-1f386c649-d22c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE extended-release tablets, for oral use Initial U.S. Approval: 1994
50090-5806-22023-01-30C16284748780-1f386c649-d22c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE extended-release tablets, for oral use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5806-0Glipizide30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE308
50090-5806-1Glipizide60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE608
50090-5806-2Glipizide90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5806-0EA - Each50090-5806b2820ca7-7952-42c3-83e7-feb0c5a913b012022-07-06
50090-5806-1EA - Each50090-5806d9b94499-53bc-492a-9642-bee275e721df12022-07-06
50090-5806-2EA - Each50090-5806af948cdb-767e-47a4-b8be-ff27d3304d8312022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5806GLIPIZIDE TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 3 package rows20231125_4982f018-c53c-48ec-a4e8-4834228bcf2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN4982f018-c53c-48ec-a4e8-4834228bcf2c8
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD4982f018-c53c-48ec-a4e8-4834228bcf2c8
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY4982f018-c53c-48ec-a4e8-4834228bcf2c8
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY4982f018-c53c-48ec-a4e8-4834228bcf2c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5806-05009058060030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5806-0) 2021-10-150000-00-00NoNoCurrent
50090-5806-15009058060160 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5806-1) 2021-10-150000-00-00NoNoCurrent
50090-5806-25009058060290 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-5806-2) 2021-10-150000-00-00NoNoCurrent