FDA.reportPublic FDA data

Glipizide

Product NDC
50090-6848
11-digit product format
500906848
Labeler code
50090
Product ID
50090-6848_4edee9b0-23a0-4e64-a8c1-3dd89d5674cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203499
Marketing category
ANDA
Marketing start
2018-12-01
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
50090-6848-0Glipizide30 in 1 BOTTLETABLET, EXTENDED RELEASE301
50090-6848-1Glipizide60 in 1 BOTTLETABLET, EXTENDED RELEASE601
50090-6848-2Glipizide90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6848GLIPIZIDE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20231205_5014a2d7-e0d3-4e84-9a3e-c90b398b8c6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN5014a2d7-e0d3-4e84-9a3e-c90b398b8c6c1
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD5014a2d7-e0d3-4e84-9a3e-c90b398b8c6c1
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY5014a2d7-e0d3-4e84-9a3e-c90b398b8c6c1
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY5014a2d7-e0d3-4e84-9a3e-c90b398b8c6c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6848-05009068480030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6848-0) 2023-11-29NoNoCurrent
50090-6848-15009068480160 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6848-1) 2023-11-29NoNoCurrent
50090-6848-25009068480290 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6848-2) 2023-11-29NoNoCurrent