FDA.reportPublic FDA data

Glipizide

Product NDC
50090-6746
11-digit product format
500906746
Labeler code
50090
Product ID
50090-6746_83177dee-9da4-409b-a28d-56390f9c0d6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
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
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
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
50090-6746-0Glipizide30 in 1 BOTTLETABLET, EXTENDED RELEASE302
50090-6746-1Glipizide60 in 1 BOTTLETABLET, EXTENDED RELEASE602
50090-6746-2Glipizide90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6746GLIPIZIDE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]2Current NDC, 3 package rows20231019_695c178f-77f0-451e-b718-72b65e495b7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSN695c178f-77f0-451e-b718-72b65e495b7e2
31400624 HR glipizide 5 MG Extended Release Oral TabletSCD695c178f-77f0-451e-b718-72b65e495b7e2
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSY695c178f-77f0-451e-b718-72b65e495b7e2
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSY695c178f-77f0-451e-b718-72b65e495b7e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6746-05009067460030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6746-0) 2023-10-18NoNoCurrent
50090-6746-15009067460160 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6746-1) 2023-10-16NoNoCurrent
50090-6746-25009067460290 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6746-2) 2023-10-16NoNoCurrent