FDA.reportPublic FDA data

Glipizide

Product NDC
71610-680
11-digit product format
716100680
Labeler code
71610
Product ID
71610-680_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
5 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
GLIPIZIDE5 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
71610-680-45Glipizide45 in 1 BOTTLETABLET455
71610-680-60Glipizide90 in 1 BOTTLETABLET905
71610-680-73Glipizide135 in 1 BOTTLETABLET1355
71610-680-80Glipizide180 in 1 BOTTLETABLET1805
71610-680-92Glipizide270 in 1 BOTTLETABLET2705
71610-680-98Glipizide540 in 1 BOTTLETABLET5405

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-680-45EA - Each71610-680579d06ea-9dee-442b-b0bc-236c533f541012023-12-05
71610-680-60EA - Each71610-6809a251642-68cf-4f6c-acf3-7b574fed6a4812024-01-04
71610-680-73EA - Each71610-6805fb20721-74c8-40a2-aa52-7f2cbb83c44512024-04-05
71610-680-80EA - Each71610-6805172b557-fa8e-4f7d-96fe-9c88eac48ea012024-01-04
71610-680-92EA - Each71610-680e104259d-c6f0-4e9c-9033-546046f89b9212024-01-04
71610-680-98EA - Each71610-68029872a89-e891-4f4a-b496-5f3fd1f990e312024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-680GLIPIZIDE 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
71610-680-457161006804545 TABLET in 1 BOTTLE (71610-680-45) 45 tablet2022-12-090000-00-00NoNoCurrent
71610-680-607161006806090 TABLET in 1 BOTTLE (71610-680-60) 90 tablet2022-12-090000-00-00NoNoCurrent
71610-680-7371610068073135 TABLET in 1 BOTTLE (71610-680-73) 135 tablet2023-04-14NoNoHistorical
71610-680-8071610068080180 TABLET in 1 BOTTLE (71610-680-80) 180 tablet2022-12-090000-00-00NoNoCurrent
71610-680-9271610068092270 TABLET in 1 BOTTLE (71610-680-92) 270 tablet2022-12-090000-00-00NoNoCurrent
71610-680-9871610068098540 TABLET in 1 BOTTLE (71610-680-98) 540 tablet2023-03-17NoNoHistorical