FDA.reportPublic FDA data

Glipizide

Product NDC
50090-6765
11-digit product format
500906765
Labeler code
50090
Product ID
50090-6765_307a539f-739a-4909-b41e-3fe98624cb53
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
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
b1de1ca9-d9db-4f4b-2103-09e2014d30d5Product name520180912
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6765-0Glipizide30 in 1 BOTTLETABLET, EXTENDED RELEASE303
50090-6765-1Glipizide60 in 1 BOTTLETABLET, EXTENDED RELEASE603
50090-6765-2Glipizide90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6765-1EA - Each50090-6765c48c82c0-5ac3-40c4-8571-c057bf2f2ccf12023-12-05
50090-6765-2EA - Each50090-6765ae47575e-25ab-4302-92ab-d3462848415012023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6765GLIPIZIDE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]3Current NDC, 3 package rows20231024_08b01608-73c2-45e0-8de4-c6c401261152.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN08b01608-73c2-45e0-8de4-c6c4012611523
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD08b01608-73c2-45e0-8de4-c6c4012611523
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY08b01608-73c2-45e0-8de4-c6c4012611523
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY08b01608-73c2-45e0-8de4-c6c4012611523

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6765-05009067650030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6765-0) 2023-10-19NoNoCurrent
50090-6765-15009067650160 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6765-1) 2023-10-19NoNoCurrent
50090-6765-25009067650290 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6765-2) 2023-10-19NoNoCurrent