FDA.reportPublic FDA data

Glipizide

Product NDC
51655-180
11-digit product format
516550180
Labeler code
51655
Product ID
51655-180_48c42223-ff56-f7b4-e063-6294a90a9284
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA075795
Marketing category
ANDA
Marketing start
2020-06-04
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
Rxcui310490

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-180-262023-03-23C16284748780-1f386c649-f246-0266-e053-dadaa90a7c1aGLIPIZIDE TABLETS, USP 5 mg Rx Only
51655-180-262023-01-30C16284748780-1f386c649-f246-0266-e053-dadaa90a7c1aGLIPIZIDE TABLETS, USP 5 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-180-25Glipizide60 in 1 BOTTLE, PLASTICTABLET603
51655-180-26Glipizide90 in 1 BOTTLE, PLASTICTABLET903
51655-180-52Glipizide30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51655-180-26EA - Each51655-1800815f3d3-1f87-4475-90d6-2700218dd4ea12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-180GLIPIZIDE TABLET [NORTHWIND PHARMACEUTICALS]2Current NDC, Legacy NDC, 3 package rows20230324_c16edad6-4271-6ff0-e053-2a95a90a0240.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310490glipiZIDE 5 MG Oral TabletPSNc16edad6-4271-6ff0-e053-2a95a90a02403
310490glipizide 5 MG Oral TabletSCDc16edad6-4271-6ff0-e053-2a95a90a02403

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-180-255165501802560 TABLET in 1 BOTTLE, PLASTIC (51655-180-25) 60 tablet2022-12-05NoNoHistorical
51655-180-265165501802690 TABLET in 1 BOTTLE, PLASTIC (51655-180-26) 90 tablet2020-06-040000-00-00NoNoCurrent
51655-180-525165501805230 TABLET in 1 BOTTLE, PLASTIC (51655-180-52) 30 tablet2022-03-30NoNoHistorical