FDA.reportPublic FDA data

Glucotrol

Product NDC
0049-0174
11-digit product format
000490174
Labeler code
0049
Product ID
0049-0174_ce46d6b5-eab4-4630-8480-f13885be938e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glipizide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Roerig
Application
NDA020329
Marketing category
NDA
Marketing start
2013-05-09
Marketing end
2027-07-31
Substance
GLIPIZIDE
Active strength
5 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Glucotrol
Brand name suffix
XL

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIPIZIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX7WDT95N5C
Rxcui310489, 314006, 315107, 865568, 865571, 865573

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
0049-0174-02GlucotrolXL100 in 1 BOTTLETABLET, EXTENDED RELEASE10027
0049-0174-03GlucotrolXL500 in 1 BOTTLETABLET, EXTENDED RELEASE50027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0049-0174-02EA - Each0049-017431c9feae-f69f-4dca-ac24-8e514cc2ec2b12013-06-04
0049-0174-03EA - Each0049-0174ff36cddf-e5aa-451c-ac46-1f05c5814c4212013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIPIZIDEACTIVE INGREDIENTX7WDT95N5CGLUCOTROL XL (GLIPIZIDE) TABLET, EXTENDED RELEASE [ROERIG]11
GLIPIZIDEACTIVE MOIETYX7WDT95N5CGLUCOTROL XL (GLIPIZIDE) TABLET, EXTENDED RELEASE [ROERIG]11
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6GLUCOTROL XL (GLIPIZIDE) TABLET, EXTENDED RELEASE [ROERIG]11
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GLUCOTROL XL (GLIPIZIDE) TABLET, EXTENDED RELEASE [ROERIG]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGLUCOTROL XL (GLIPIZIDE) TABLET, EXTENDED RELEASE [ROERIG]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLUCOTROL XL (GLIPIZIDE) TABLET, EXTENDED RELEASE [ROERIG]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGLUCOTROL XL (GLIPIZIDE) TABLET, EXTENDED RELEASE [ROERIG]11
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XGLUCOTROL XL (GLIPIZIDE) TABLET, EXTENDED RELEASE [ROERIG]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0049-0174GLUCOTROL XL (GLIPIZIDE) TABLET, EXTENDED RELEASE [ROERIG]27Current NDC, Legacy NDC, 2 package rows20250406_eed99b60-d043-4249-9b2a-f05e46fb588d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
315107glipiZIDE 10 MG 24HR Extended Release Oral TabletPSNeed99b60-d043-4249-9b2a-f05e46fb588d27
310489glipiZIDE 2.5 MG 24HR Extended Release Oral TabletPSNeed99b60-d043-4249-9b2a-f05e46fb588d27
314006glipiZIDE 5 MG 24HR Extended Release Oral TabletPSNeed99b60-d043-4249-9b2a-f05e46fb588d27
865568Glucotrol XL 10 MG 24HR Extended Release Oral TabletPSNeed99b60-d043-4249-9b2a-f05e46fb588d27
865571Glucotrol XL 2.5 MG 24HR Extended Release Oral TabletPSNeed99b60-d043-4249-9b2a-f05e46fb588d27
865573Glucotrol XL 5 MG 24HR Extended Release Oral TabletPSNeed99b60-d043-4249-9b2a-f05e46fb588d27
86556824 HR glipizide 10 MG Extended Release Oral Tablet [Glucotrol]SBDeed99b60-d043-4249-9b2a-f05e46fb588d27
86557124 HR glipizide 2.5 MG Extended Release Oral Tablet [Glucotrol]SBDeed99b60-d043-4249-9b2a-f05e46fb588d27
86557324 HR glipizide 5 MG Extended Release Oral Tablet [Glucotrol]SBDeed99b60-d043-4249-9b2a-f05e46fb588d27
31510724 HR glipizide 10 MG Extended Release Oral TabletSCDeed99b60-d043-4249-9b2a-f05e46fb588d27
31048924 HR glipizide 2.5 MG Extended Release Oral TabletSCDeed99b60-d043-4249-9b2a-f05e46fb588d27
31400624 HR glipizide 5 MG Extended Release Oral TabletSCDeed99b60-d043-4249-9b2a-f05e46fb588d27
86556824 HR Glucotrol XL 10 MG Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27
86557124 HR Glucotrol XL 2.5 MG Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27
86557324 HR Glucotrol XL 5 MG Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27
315107glipizide ER 10 MG 24 HR Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27
310489glipizide ER 2.5 MG 24 HR Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27
314006glipizide ER 5 MG 24 HR Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27
315107glipizide XL 10 MG 24 HR Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27
310489glipizide XL 2.5 MG 24 HR Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27
314006glipizide XL 5 MG 24 HR Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27
865568Glucotrol XL 10 MG 24 HR Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27
865571Glucotrol XL 2.5 MG 24 HR Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27
865573Glucotrol XL 5 MG 24 HR Extended Release Oral TabletSYeed99b60-d043-4249-9b2a-f05e46fb588d27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0049-0174-0200049017402100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0174-02) 2013-05-092027-07-31NoNoCurrent
0049-0174-0300049017403500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0174-03) 2013-05-092027-07-31NoNoCurrent