FDA.reportPublic FDA data

Glipizide

Product NDC
82868-035
11-digit product format
828680035
Labeler code
82868
Product ID
82868-035_46dcb2f2-0db6-f108-e063-6294a90a28ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA206928
Marketing category
ANDA
Marketing start
2024-01-09
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
Rxcui315107

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
82868-035-30Glipizide30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE303
82868-035-90Glipizide90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82868-035GLIPIZIDE TABLET, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240302_0effd04d-172c-5d8c-e063-6294a90a93f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN0effd04d-172c-5d8c-e063-6294a90a93f43
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD0effd04d-172c-5d8c-e063-6294a90a93f43
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY0effd04d-172c-5d8c-e063-6294a90a93f43
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY0effd04d-172c-5d8c-e063-6294a90a93f43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82868-035-308286800353030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82868-035-30) 2024-01-09NoNoHistorical
82868-035-908286800359090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82868-035-90) 2024-02-15NoNoHistorical