FDA.reportPublic FDA data

Glipizide

Product NDC
59651-781
11-digit product format
596510781
Labeler code
59651
Product ID
59651-781_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
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
GLIPIZIDE5 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
59651-781-01Glipizide100 in 1 BOTTLETABLET, EXTENDED RELEASE1002
59651-781-05Glipizide500 in 1 BOTTLETABLET, EXTENDED RELEASE5002
59651-781-30Glipizide30 in 1 BOTTLETABLET, EXTENDED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-781-01EA - Each59651-78125c04ad6-2c95-4dc6-81c9-2b3c5106255312023-04-07
59651-781-05EA - Each59651-7817bb53826-7269-4234-977a-a261a9d0e48f12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-781GLIPIZIDE TABLET, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]1Current NDC, 3 package rows20230308_84794a52-b717-488c-8533-6425c83d405f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSN4afa67b2-7f86-4189-93a5-6a605f74540d101
31400624 HR glipizide 5 MG Extended Release Oral TabletSCD4afa67b2-7f86-4189-93a5-6a605f74540d101
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSY4afa67b2-7f86-4189-93a5-6a605f74540d101
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSY4afa67b2-7f86-4189-93a5-6a605f74540d101
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSN0df8f606-97b3-463c-a132-338cf4630a714
31400624 HR glipizide 5 MG Extended Release Oral TabletSCD0df8f606-97b3-463c-a132-338cf4630a714
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSY0df8f606-97b3-463c-a132-338cf4630a714
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSY0df8f606-97b3-463c-a132-338cf4630a714
310489glipiZIDE 2.5 MG 24HR Extended Release Oral TabletPSNaaf029d3-027e-4ae8-8ec5-3a4c16f9bd283
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSN0a1e1152-ade7-2092-e063-6394a90a99e73
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
31400624 HR glipizide 5 MG Extended Release Oral TabletSCD0a1e1152-ade7-2092-e063-6394a90a99e73
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
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSY0a1e1152-ade7-2092-e063-6394a90a99e73
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
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSY0a1e1152-ade7-2092-e063-6394a90a99e73
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
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSN695c178f-77f0-451e-b718-72b65e495b7e2
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
31400624 HR glipizide 5 MG Extended Release Oral TabletSCD695c178f-77f0-451e-b718-72b65e495b7e2
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
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSY695c178f-77f0-451e-b718-72b65e495b7e2
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
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSY695c178f-77f0-451e-b718-72b65e495b7e2
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSN1b2ef6e2-5e7c-761e-e063-6294a90addd01
31400624 HR glipizide 5 MG Extended Release Oral TabletSCD1b2ef6e2-5e7c-761e-e063-6294a90addd01
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSY1b2ef6e2-5e7c-761e-e063-6294a90addd01
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSY1b2ef6e2-5e7c-761e-e063-6294a90addd01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-781-0159651078101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-781-01) 2023-03-03NoNoCurrent
59651-781-0559651078105500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-781-05) 2023-03-03NoNoCurrent
59651-781-305965107813030 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-781-30) 2023-03-03NoNoCurrent
59651-781-71596510781717000 TABLET, EXTENDED RELEASE in 1 BAG (59651-781-71)03-MAR-23Current