FDA.reportPublic FDA data

GLYBURIDE

Product NDC
75834-204
11-digit product format
758340204
Labeler code
75834
Product ID
75834-204_757b12d9-8efb-49ca-b8f7-7884535ca011
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLYBURIDE
Dosage form
TABLET
Route
ORAL
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA203379
Marketing category
ANDA
Marketing start
2019-01-25
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
Rxcui197737, 310534, 310537

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
75834-204-00GLYBURIDE1000 in 1 BOTTLETABLET10002
75834-204-01GLYBURIDE100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-204-00EA - Each75834-2041d842e37-c54c-45c4-bc0e-ae004aaa7fa312019-06-19
75834-204-01EA - Each75834-204faf9bb68-b71a-45ca-aea0-6bfafc913ef112019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-204GLYBURIDE TABLET [NIVAGEN PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20210115_43c6f68b-5747-47c6-9538-51ef8c611db4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197737glyBURIDE 1.25 MG Oral TabletPSN43c6f68b-5747-47c6-9538-51ef8c611db42
310534glyBURIDE 2.5 MG Oral TabletPSN43c6f68b-5747-47c6-9538-51ef8c611db42
310537glyBURIDE 5 MG Oral TabletPSN43c6f68b-5747-47c6-9538-51ef8c611db42
197737glyburide 1.25 MG Oral TabletSCD43c6f68b-5747-47c6-9538-51ef8c611db42
310534glyburide 2.5 MG Oral TabletSCD43c6f68b-5747-47c6-9538-51ef8c611db42
310537glyburide 5 MG Oral TabletSCD43c6f68b-5747-47c6-9538-51ef8c611db42
197737glibenclamide 1.25 MG Oral TabletSY43c6f68b-5747-47c6-9538-51ef8c611db42
310534glibenclamide 2.5 MG Oral TabletSY43c6f68b-5747-47c6-9538-51ef8c611db42
310537glibenclamide 5 MG Oral TabletSY43c6f68b-5747-47c6-9538-51ef8c611db42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-204-00758340204001000 TABLET in 1 BOTTLE (75834-204-00) 1000 tablet2019-01-250000-00-00NoNoCurrent
75834-204-0175834020401100 TABLET in 1 BOTTLE (75834-204-01) 100 tablet2019-01-250000-00-00NoNoCurrent