FDA.reportPublic FDA data

Glyburide

Product NDC
68788-8508
11-digit product format
687888508
Labeler code
68788
Product ID
68788-8508_a4d8afca-575f-43ba-9a84-30c00a07a015
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA203379
Marketing category
ANDA
Marketing start
2023-08-16
Substance
GLYBURIDE
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
Glyburide
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8508-1Glyburide100 in 1 BOTTLETABLET1004
68788-8508-3Glyburide30 in 1 BOTTLETABLET304
68788-8508-6Glyburide60 in 1 BOTTLETABLET604
68788-8508-9Glyburide90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8508-1EA - Each68788-85083a4becec-d1e8-4b49-bd8a-3b36fca8663e12023-10-16
68788-8508-3EA - Each68788-850867ba0f47-f380-47c5-9b09-6bbe4087146f12023-10-16
68788-8508-6EA - Each68788-85088e1ababd-cef1-4ab0-bc5c-ff74d1d3ef2012023-10-16
68788-8508-9EA - Each68788-8508fee2326f-881f-492c-9b20-1110e3b0fa7512023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8508GLYBURIDE TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 4 package rows20240517_cf21c8c0-7247-4d5b-97f8-ae4016144642.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310537glyBURIDE 5 MG Oral TabletPSNcf21c8c0-7247-4d5b-97f8-ae40161446424
310537glyburide 5 MG Oral TabletSCDcf21c8c0-7247-4d5b-97f8-ae40161446424
310537glibenclamide 5 MG Oral TabletSYcf21c8c0-7247-4d5b-97f8-ae40161446424

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8508-168788850801100 TABLET in 1 BOTTLE (68788-8508-1) 100 tablet2023-08-16NoNoHistorical
68788-8508-36878885080330 TABLET in 1 BOTTLE (68788-8508-3) 30 tablet2023-08-16NoNoHistorical
68788-8508-66878885080660 TABLET in 1 BOTTLE (68788-8508-6) 60 tablet2023-08-16NoNoHistorical
68788-8508-96878885080990 TABLET in 1 BOTTLE (68788-8508-9) 90 tablet2023-08-16NoNoHistorical