FDA.reportPublic FDA data

Glipizide

Product NDC
72789-463
11-digit product format
727890463
Labeler code
72789
Product ID
72789-463_4db296fd-1dbc-d073-e063-6294a90a3d70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA214874
Marketing category
ANDA
Marketing start
2023-10-03
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
Rxcui310488

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
72789-463-86Glipizide360 in 1 BOTTLE, PLASTICTABLET3607
72789-463-90Glipizide90 in 1 BOTTLE, PLASTICTABLET907
72789-463-93Glipizide180 in 1 BOTTLE, PLASTICTABLET1807
72789-463-95Glipizide1000 in 1 BOTTLE, PLASTICTABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-463-86EA - Each72789-4633016af31-ec09-47bd-abca-a614cb4dbfaf12026-03-17
72789-463-90EA - Each72789-463ca9d9c85-99a9-4a41-86f1-cdbfa4afe54212025-02-10
72789-463-93EA - Each72789-4639e6811cf-d87e-4933-b8e8-ee488fa4901612025-02-10
72789-463-95EA - Each72789-463e41280a8-575c-415d-9359-69c288a4573b12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-463GLIPIZIDE TABLET [PD-RX PHARMACEUTICALS, INC.]4Current NDC, 4 package rows20250108_d9b6464f-6fe6-446e-8150-d0c15c46fee8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310488glipiZIDE 10 MG Oral TabletPSNd9b6464f-6fe6-446e-8150-d0c15c46fee87
310488glipizide 10 MG Oral TabletSCDd9b6464f-6fe6-446e-8150-d0c15c46fee87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-463-8672789046386360 TABLET in 1 BOTTLE, PLASTIC (72789-463-86) 360 tablet2026-02-17NoNoHistorical
72789-463-907278904639090 TABLET in 1 BOTTLE, PLASTIC (72789-463-90) 90 tablet2024-12-23NoNoHistorical
72789-463-9372789046393180 TABLET in 1 BOTTLE, PLASTIC (72789-463-93) 180 tablet2024-12-23NoNoHistorical
72789-463-95727890463951000 TABLET in 1 BOTTLE, PLASTIC (72789-463-95) 1000 tablet2024-12-23NoNoHistorical