FDA.reportPublic FDA data

Glipizide

Product NDC
71610-668
11-digit product format
716100668
Labeler code
71610
Product ID
71610-668_737c6102-3cac-4ef5-812b-13e0298c7210
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA074497
Marketing category
ANDA
Marketing start
1995-08-31
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
Rxcui310488, 310490

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
71610-668-53Glipizide60 in 1 BOTTLETABLET605
71610-668-60Glipizide90 in 1 BOTTLETABLET905
71610-668-70Glipizide120 in 1 BOTTLETABLET1205
71610-668-80Glipizide180 in 1 BOTTLETABLET1805
71610-668-92Glipizide270 in 1 BOTTLETABLET2705
71610-668-94Glipizide360 in 1 BOTTLETABLET3605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-668-53EA - Each71610-6687f752aae-0c78-4ace-ac53-f73a49bea21612022-12-07
71610-668-60EA - Each71610-66857d0f120-48d0-45b3-b534-695a60bc29a712022-12-07
71610-668-70EA - Each71610-668b53f5a43-e90b-49ff-ae62-fcedafa13f4912022-12-07
71610-668-80EA - Each71610-6683712de19-a1c0-4acd-925a-7fe536518d4012022-12-07
71610-668-92EA - Each71610-66896d28640-cc28-4a37-9da8-ae0a11bb2aa312022-12-07
71610-668-94EA - Each71610-66878a21648-4856-4ad0-9656-0d2871df1e3a12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-668GLIPIZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]5Current NDC, Legacy NDC, 6 package rows20230416_64c2a82f-014c-47d7-b303-23531e6bb723.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310488glipiZIDE 10 MG Oral TabletPSN64c2a82f-014c-47d7-b303-23531e6bb7235
310490glipiZIDE 5 MG Oral TabletPSN64c2a82f-014c-47d7-b303-23531e6bb7235
310488glipizide 10 MG Oral TabletSCD64c2a82f-014c-47d7-b303-23531e6bb7235
310490glipizide 5 MG Oral TabletSCD64c2a82f-014c-47d7-b303-23531e6bb7235

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-668-537161006685360 TABLET in 1 BOTTLE (71610-668-53) 60 tablet2022-10-100000-00-00NoNoCurrent
71610-668-607161006686090 TABLET in 1 BOTTLE (71610-668-60) 90 tablet2022-10-100000-00-00NoNoCurrent
71610-668-7071610066870120 TABLET in 1 BOTTLE (71610-668-70) 120 tablet2022-10-100000-00-00NoNoCurrent
71610-668-8071610066880180 TABLET in 1 BOTTLE (71610-668-80) 180 tablet2022-10-100000-00-00NoNoCurrent
71610-668-9271610066892270 TABLET in 1 BOTTLE (71610-668-92) 270 tablet2022-10-100000-00-00NoNoCurrent
71610-668-9471610066894360 TABLET in 1 BOTTLE (71610-668-94) 360 tablet2022-10-100000-00-00NoNoCurrent