FDA.reportPublic FDA data

Glipizide

Product NDC
16714-895
11-digit product format
167140895
Labeler code
16714
Product ID
16714-895_26f0c341-a482-4dc1-aaef-f0a92a84937c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Northstar Rx LLC.
Application
ANDA203499
Marketing category
ANDA
Marketing start
2018-12-01
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
Rxcui310489, 314006, 315107

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
16714-895-01Glipizide100 in 1 BOTTLETABLET, EXTENDED RELEASE1004
16714-895-02Glipizide500 in 1 BOTTLETABLET, EXTENDED RELEASE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-895-01EA - Each16714-895d5c68515-aa65-434e-838b-35a736cab36b12019-05-02
16714-895-02EA - Each16714-895afdd444e-a53b-4ee9-b5bb-2d1d3706cc5812019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-895GLIPIZIDE TABLET, EXTENDED RELEASE [NORTHSTAR RX LLC.]3Current NDC, Legacy NDC, 2 package rows20221130_915636a4-092e-4e2e-9bc0-0d387d996977.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSN915636a4-092e-4e2e-9bc0-0d387d9969774
310489glipiZIDE 2.5 MG 24HR Extended Release Oral TabletPSN915636a4-092e-4e2e-9bc0-0d387d9969774
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSN915636a4-092e-4e2e-9bc0-0d387d9969774
31510724 HR glipizide 10 MG Extended Release Oral TabletSCD915636a4-092e-4e2e-9bc0-0d387d9969774
31048924 HR glipizide 2.5 MG Extended Release Oral TabletSCD915636a4-092e-4e2e-9bc0-0d387d9969774
31400624 HR glipizide 5 MG Extended Release Oral TabletSCD915636a4-092e-4e2e-9bc0-0d387d9969774
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSY915636a4-092e-4e2e-9bc0-0d387d9969774
310489glipizide ER 2.5 MG 24 HR Extended Release Oral TabletSY915636a4-092e-4e2e-9bc0-0d387d9969774
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSY915636a4-092e-4e2e-9bc0-0d387d9969774
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSY915636a4-092e-4e2e-9bc0-0d387d9969774
310489glipizide XL 2.5 MG 24 HR Extended Release Oral TabletSY915636a4-092e-4e2e-9bc0-0d387d9969774
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSY915636a4-092e-4e2e-9bc0-0d387d9969774
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSNd09880af-afdb-470a-8731-fcc885c524673
31400624 HR glipizide 5 MG Extended Release Oral TabletSCDd09880af-afdb-470a-8731-fcc885c524673
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSYd09880af-afdb-470a-8731-fcc885c524673
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSYd09880af-afdb-470a-8731-fcc885c524673

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-895-0116714089501100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-895-01) 2018-12-010000-00-00NoNoCurrent
16714-895-0216714089502500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-895-02) 2018-12-010000-00-00NoNoCurrent