FDA.reportPublic FDA data

Glyburide

Product NDC
66267-103
11-digit product format
662670103
Labeler code
66267
Product ID
66267-103_1f98dd6f-ab6b-c359-e063-6394a90af09e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA090937
Marketing category
ANDA
Marketing start
2010-10-05
Substance
GLYBURIDE
Active strength
5 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
Glyburide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYBURIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSX6K58TVWC
Rxcui310537

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bea938a6-c880-985b-d27b-b59b0d8b5a77Product name320170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2fProduct name120170616
64b2b6e2-1c04-cf4a-db4c-078ed10e1dd6Product name220160609
5a2baaae-1290-c05e-207f-b1367e9eb46aProduct name220151005
b044018d-bcdc-e68d-63da-1ad6886aea64Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66267-103-302024-08-13C16284748780-1f386c649-c513-0266-e053-dadaa90a7c1afor oral use
66267-103-602024-08-13C16284748780-1f386c649-c513-0266-e053-dadaa90a7c1afor oral use
66267-103-902024-08-13C16284748780-1f386c649-c513-0266-e053-dadaa90a7c1afor oral use
66267-103-912024-08-13C16284748780-1f386c649-c513-0266-e053-dadaa90a7c1afor oral use
66267-103-302023-01-30C16284748780-1f386c649-c513-0266-e053-dadaa90a7c1afor oral use
66267-103-602023-01-30C16284748780-1f386c649-c513-0266-e053-dadaa90a7c1afor oral use
66267-103-902023-01-30C16284748780-1f386c649-c513-0266-e053-dadaa90a7c1afor oral use
66267-103-912023-01-30C16284748780-1f386c649-c513-0266-e053-dadaa90a7c1afor oral use

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-103-30Glyburide30 in 1 BOTTLETABLET304
66267-103-60Glyburide60 in 1 BOTTLETABLET604
66267-103-90Glyburide90 in 1 BOTTLETABLET904
66267-103-91Glyburide120 in 1 BOTTLETABLET1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-103GLYBURIDE TABLET [NUCARE PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 4 package rows20240815_3e354b4d-70e4-5089-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310537glyBURIDE 5 MG Oral TabletPSN3e354b4d-70e4-5089-e054-00144ff88e884
310537glyburide 5 MG Oral TabletSCD3e354b4d-70e4-5089-e054-00144ff88e884
310537glibenclamide 5 MG Oral TabletSY3e354b4d-70e4-5089-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-103-306626701033030 TABLET in 1 BOTTLE (66267-103-30) 30 tablet2016-10-060000-00-00NoNoCurrent
66267-103-606626701036060 TABLET in 1 BOTTLE (66267-103-60) 60 tablet2016-10-060000-00-00NoNoCurrent
66267-103-906626701039090 TABLET in 1 BOTTLE (66267-103-90) 90 tablet2016-10-060000-00-00NoNoCurrent
66267-103-9166267010391120 TABLET in 1 BOTTLE (66267-103-91) 120 tablet2016-10-060000-00-00NoNoCurrent