Glimepiride

Product NDC
33261-892
11-digit product format
332610892
Labeler code
33261
Product ID
33261-892_0bbcdb96-76b4-4d74-a385-9ead00baa8ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA077091
Marketing category
ANDA
Marketing start
2005-10-06
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
4 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b890b964-2cf0-4439-aaf3-900c9e3e9e49Product name120160602
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
d36d861f-8a90-80cc-8935-1e6be9b4c7ebProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-892-30Glimepiride30 in 1 BOTTLE, PLASTICTABLET301
33261-892-60Glimepiride60 in 1 BOTTLE, PLASTICTABLET601
33261-892-90Glimepiride90 in 1 BOTTLE, PLASTICTABLET901
33261-892-99Glimepiride180 in 1 BOTTLE, PLASTICTABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-892-30EA - Each33261-892a019e4ab-45bb-469c-9ce0-e73b484bf0dc12015-10-02
33261-892-60EA - Each33261-892db19ac26-0523-4e79-adc7-4473a999e0bd12015-10-02
33261-892-90EA - Each33261-892c85ff86c-6df2-4d4d-b3e1-9413ba6b0f7112015-10-02
33261-892-99EA - Each33261-892cf6504c1-9ceb-4c2d-8430-81d1198a9d3f12016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-892GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20140110_9275a6af-b7f2-4d1a-b412-14a3c611e6f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199247glimepiride 4 MG Oral TabletPSN9275a6af-b7f2-4d1a-b412-14a3c611e6f81
199247glimepiride 4 MG Oral TabletSCD9275a6af-b7f2-4d1a-b412-14a3c611e6f81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-892-303326108923030 in 1 BOTTLE, PLASTICHistorical
33261-892-603326108926060 in 1 BOTTLE, PLASTICHistorical
33261-892-903326108929090 in 1 BOTTLE, PLASTICHistorical
33261-892-9933261089299180 in 1 BOTTLE, PLASTICHistorical