FDA.reportPublic FDA data

Glimepiride

Product NDC
43063-122
11-digit product format
430630122
Labeler code
43063
Product ID
43063-122_41372f7a-4296-6e3d-e063-6394a90af659
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077091
Marketing category
ANDA
Marketing start
2005-10-06
Substance
GLIMEPIRIDE
Active strength
4 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
Glimepiride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIMEPIRIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6KY687524K
Rxcui199247

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-122-30Glimepiride30 in 1 BOTTLE, PLASTICTABLET3018
43063-122-90Glimepiride90 in 1 BOTTLE, PLASTICTABLET9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-122-30EA - Each43063-12243d2bacb-7958-4e5b-aefb-21a04ea49eec12012-07-24
43063-122-90EA - Each43063-12279baee10-e21e-4121-a03d-04ba0899cf8712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]3
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]3
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]3
povidoneINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-122GLIMEPIRIDE TABLET [PD-RX PHARMACEUTICALS, INC.]17Current NDC, 2 package rows20241222_101cdc41-2131-4425-b550-6a0a60b5f4a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199247glimepiride 4 MG Oral TabletPSN101cdc41-2131-4425-b550-6a0a60b5f4a418
199247glimepiride 4 MG Oral TabletSCD101cdc41-2131-4425-b550-6a0a60b5f4a418

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43063-122-304306301223030 TABLET in 1 BOTTLE, PLASTIC (43063-122-30) 30 tablet2024-12-19NoNoCurrent
43063-122-904306301229090 TABLET in 1 BOTTLE, PLASTIC (43063-122-90) 90 tablet2009-12-23NoNoCurrent