FDA.reportPublic FDA data

Glipizide

Product NDC
59651-782
11-digit product format
596510782
Labeler code
59651
Product ID
59651-782_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
10 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
GLIPIZIDE10 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
59651-782-01Glipizide100 in 1 BOTTLETABLET, EXTENDED RELEASE1002
59651-782-05Glipizide500 in 1 BOTTLETABLET, EXTENDED RELEASE5002
59651-782-30Glipizide30 in 1 BOTTLETABLET, EXTENDED RELEASE302
59651-782-99Glipizide1000 in 1 BOTTLETABLET, EXTENDED RELEASE10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-782-01EA - Each59651-7822e8276b0-a966-4576-9588-68b09a5317db12023-04-07
59651-782-05EA - Each59651-782f919fcfc-606b-46c3-856d-edfe18e1022512023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-782GLIPIZIDE TABLET, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]1Current NDC, 4 package rows20230308_84794a52-b717-488c-8533-6425c83d405f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN2aa01a7e-a703-426f-9cd3-70b88d0a8e7f101
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD2aa01a7e-a703-426f-9cd3-70b88d0a8e7f101
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY2aa01a7e-a703-426f-9cd3-70b88d0a8e7f101
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY2aa01a7e-a703-426f-9cd3-70b88d0a8e7f101
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSNceb86ebb-d00a-4261-90ad-8751e799d93c100
31510724 HR glipizide 10 MG Extended Release Oral TabletSCDceb86ebb-d00a-4261-90ad-8751e799d93c100
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSYceb86ebb-d00a-4261-90ad-8751e799d93c100
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSYceb86ebb-d00a-4261-90ad-8751e799d93c100
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN667dd68a-d3e7-4b50-bd0a-d17783a090d54
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD667dd68a-d3e7-4b50-bd0a-d17783a090d54
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY667dd68a-d3e7-4b50-bd0a-d17783a090d54
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY667dd68a-d3e7-4b50-bd0a-d17783a090d54
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN0effd04d-172c-5d8c-e063-6294a90a93f43
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN08b01608-73c2-45e0-8de4-c6c4012611523
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD0effd04d-172c-5d8c-e063-6294a90a93f43
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD08b01608-73c2-45e0-8de4-c6c4012611523
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY0effd04d-172c-5d8c-e063-6294a90a93f43
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY08b01608-73c2-45e0-8de4-c6c4012611523
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY0effd04d-172c-5d8c-e063-6294a90a93f43
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY08b01608-73c2-45e0-8de4-c6c4012611523
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
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN0ccc17ca-fff8-0449-e063-6294a90af36d1
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD0ccc17ca-fff8-0449-e063-6294a90af36d1
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY0ccc17ca-fff8-0449-e063-6294a90af36d1
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY0ccc17ca-fff8-0449-e063-6294a90af36d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-782-0159651078201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-782-01) 2023-03-03NoNoHistorical
59651-782-0559651078205500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-782-05) 2023-03-03NoNoHistorical
59651-782-305965107823030 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-782-30) 2023-03-03NoNoHistorical
59651-782-99596510782991000 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-782-99) 2023-03-03NoNoHistorical