FDA.reportPublic FDA data

Glipizide

Product NDC
59651-780
11-digit product format
596510780
Labeler code
59651
Product ID
59651-780_7d29a701-73cf-42ce-9068-b9a5153fdb56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA206928
Marketing category
ANDA
Marketing start
2023-03-03
Substance
GLIPIZIDE
Active strength
2.5 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
GLIPIZIDE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX7WDT95N5C
Rxcui310489, 314006, 315107

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
59651-780-30Glipizide30 in 1 BOTTLETABLET, EXTENDED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-780-30EA - Each59651-7809f7c21d0-14a2-4c1d-a041-ee6bb5efc30212023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-780GLIPIZIDE TABLET, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]1Current NDC, 1 package rows20230308_84794a52-b717-488c-8533-6425c83d405f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310489glipiZIDE 2.5 MG 24HR Extended Release Oral TabletPSNaaf029d3-027e-4ae8-8ec5-3a4c16f9bd283
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSNaaf029d3-027e-4ae8-8ec5-3a4c16f9bd283
31048924 HR glipizide 2.5 MG Extended Release Oral TabletSCDaaf029d3-027e-4ae8-8ec5-3a4c16f9bd283
31400624 HR glipizide 5 MG Extended Release Oral TabletSCDaaf029d3-027e-4ae8-8ec5-3a4c16f9bd283
310489glipizide ER 2.5 MG 24 HR Extended Release Oral TabletSYaaf029d3-027e-4ae8-8ec5-3a4c16f9bd283
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSYaaf029d3-027e-4ae8-8ec5-3a4c16f9bd283
310489glipizide XL 2.5 MG 24 HR Extended Release Oral TabletSYaaf029d3-027e-4ae8-8ec5-3a4c16f9bd283
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSYaaf029d3-027e-4ae8-8ec5-3a4c16f9bd283
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN84794a52-b717-488c-8533-6425c83d405f2
310489glipiZIDE 2.5 MG 24HR Extended Release Oral TabletPSN84794a52-b717-488c-8533-6425c83d405f2
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSN84794a52-b717-488c-8533-6425c83d405f2
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD84794a52-b717-488c-8533-6425c83d405f2
31048924 HR glipizide 2.5 MG Extended Release Oral TabletSCD84794a52-b717-488c-8533-6425c83d405f2
31400624 HR glipizide 5 MG Extended Release Oral TabletSCD84794a52-b717-488c-8533-6425c83d405f2
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY84794a52-b717-488c-8533-6425c83d405f2
310489glipizide ER 2.5 MG 24 HR Extended Release Oral TabletSY84794a52-b717-488c-8533-6425c83d405f2
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSY84794a52-b717-488c-8533-6425c83d405f2
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY84794a52-b717-488c-8533-6425c83d405f2
310489glipizide XL 2.5 MG 24 HR Extended Release Oral TabletSY84794a52-b717-488c-8533-6425c83d405f2
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSY84794a52-b717-488c-8533-6425c83d405f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-780-305965107803030 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-780-30) 2023-03-03NoNoHistorical