FDA.reportPublic FDA data

Glipizide

Product NDC
51655-810
11-digit product format
516550810
Labeler code
51655
Product ID
51655-810_4973c54f-54b1-152a-e063-6294a90af0d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA074223
Marketing category
ANDA
Marketing start
2015-09-30
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-810-252023-12-18C16284748780-19d75b9d0-41b9-f424-e053-dadaa90a57ceglipiZIDE Tablets, USP for oral use Rx only
51655-810-262023-12-18C16284748780-19d75b9d0-41b9-f424-e053-dadaa90a57ceglipiZIDE Tablets, USP for oral use Rx only
51655-810-522023-12-18C16284748780-19d75b9d0-41b9-f424-e053-dadaa90a57ceglipiZIDE Tablets, USP for oral use Rx only
51655-810-252023-01-30C16284748780-19d75b9d0-41b9-f424-e053-dadaa90a57ceglipiZIDE Tablets, USP for oral use Rx only
51655-810-262023-01-30C16284748780-19d75b9d0-41b9-f424-e053-dadaa90a57ceglipiZIDE Tablets, USP for oral use Rx only
51655-810-522023-01-30C16284748780-19d75b9d0-41b9-f424-e053-dadaa90a57ceglipiZIDE Tablets, USP for oral use Rx only
51655-810-252020-07-06C16284748780-19d75b9d0-41b9-f424-e053-dadaa90a57ceglipiZIDE Tablets, USP for oral use Rx only
51655-810-522020-07-06C16284748780-19d75b9d0-41b9-f424-e053-dadaa90a57ceglipiZIDE Tablets, USP for oral use Rx only
51655-810-252020-01-31C16284748780-19d75b9d0-41b9-f424-e053-dadaa90a57ceglipiZIDE Tablets, USP for oral use Rx only
51655-810-522020-01-31C16284748780-19d75b9d0-41b9-f424-e053-dadaa90a57ceglipiZIDE Tablets, USP for oral use Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-810-25Glipizide60 in 1 BOTTLETABLET606
51655-810-26Glipizide90 in 1 BOTTLETABLET906
51655-810-52Glipizide30 in 1 BOTTLETABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51655-810-25EA - Each51655-8101472ba3f-e3c6-49a1-a508-52b7b756295812020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-810GLIPIZIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 3 package rows20241225_3bb3b80a-30e8-62fe-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310488glipiZIDE 10 MG Oral TabletPSN3bb3b80a-30e8-62fe-e054-00144ff8d46c6
310488glipizide 10 MG Oral TabletSCD3bb3b80a-30e8-62fe-e054-00144ff8d46c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-810-255165508102560 TABLET in 1 BOTTLE (51655-810-25) 60 tablet2015-09-300000-00-00NoNoCurrent
51655-810-265165508102690 TABLET in 1 BOTTLE (51655-810-26) 90 tablet2015-09-300000-00-00NoNoCurrent
51655-810-525165508105230 TABLET in 1 BOTTLE (51655-810-52) 30 tablet2015-09-300000-00-00NoNoCurrent