Glipizide

Product NDC
51655-966
11-digit product format
516550966
Labeler code
51655
Product ID
51655-966_4bc1b84a-aaee-d6e6-e063-6294a90a0762
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA204720
Marketing category
ANDA
Marketing start
2023-06-27
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
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
51655-966-26Glipizide90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE905
51655-966-52Glipizide30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-966GLIPIZIDE TABLET, FILM COATED, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240127_ff9b3b7a-5ab1-45ec-e053-6294a90af426.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSNff9b3b7a-5ab1-45ec-e053-6294a90af4265
31510724 HR glipizide 10 MG Extended Release Oral TabletSCDff9b3b7a-5ab1-45ec-e053-6294a90af4265
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSYff9b3b7a-5ab1-45ec-e053-6294a90af4265
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSYff9b3b7a-5ab1-45ec-e053-6294a90af4265

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-966-265165509662690 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-966-26) 2023-07-31NoNoHistorical
51655-966-525165509665230 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-966-52) 2023-06-27NoNoHistorical