FDA.reportPublic FDA data

Glimepiride

Product NDC
55111-320
11-digit product format
551110320
Labeler code
55111
Product ID
55111-320_e3d50334-9896-b2f9-a481-8383eb84b16a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA077091
Marketing category
ANDA
Marketing start
2005-10-06
Substance
GLIMEPIRIDE
Active strength
1 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
GLIMEPIRIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6KY687524K
Rxcui199245, 199246, 199247

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
55111-320-01Glimepiride100 in 1 BOTTLETABLET10012
55111-320-05Glimepiride500 in 1 BOTTLETABLET50012
55111-320-30Glimepiride30 in 1 BOTTLETABLET3012
55111-320-78Glimepiride100 in 1 CARTONTABLET10012
55111-320-79Glimepiride1 in 1 BLISTER PACKTABLET112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-320-01EA - Each55111-320107e9e7b-88fa-4288-9932-96095871531012012-07-24
55111-320-05EA - Each55111-320518a4018-d2c6-4f2d-8e37-3f31a0d2cac812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]7
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLIMEPIRIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLIMEPIRIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]7
ferric oxide redINACTIVE INGREDIENT1K09F3G675GLIMEPIRIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]7
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]7
magnesium stearateINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]7
PovidoneINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]7
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]3
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
ferric oxide redINACTIVE INGREDIENT1K09F3G675GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
ferric oxide redINACTIVE INGREDIENT1K09F3G675GLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]3
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
magnesium stearateINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]3
povidoneINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE (GLIMEPIRIDE ) TABLET [PD-RX PHARMACEUTICALS, INC.]3
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
magnesium stearateINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
povidoneINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-320GLIMEPIRIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]12Current NDC, Legacy NDC, 5 package rows20190130_07ad4366-4b21-f633-49f3-c2b35f88168d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSN43852c05-e091-4758-aac1-1bb3aa515b7e100
199245glimepiride 1 MG Oral TabletSCD43852c05-e091-4758-aac1-1bb3aa515b7e100
199245glimepiride 1 MG Oral TabletPSN657f1b51-2f82-44f6-a23d-97f4b34b3c4521
199245glimepiride 1 MG Oral TabletSCD657f1b51-2f82-44f6-a23d-97f4b34b3c4521
199245glimepiride 1 MG Oral TabletPSN07ad4366-4b21-f633-49f3-c2b35f88168d12
199246glimepiride 2 MG Oral TabletPSN07ad4366-4b21-f633-49f3-c2b35f88168d12
199247glimepiride 4 MG Oral TabletPSN07ad4366-4b21-f633-49f3-c2b35f88168d12
199245glimepiride 1 MG Oral TabletSCD07ad4366-4b21-f633-49f3-c2b35f88168d12
199246glimepiride 2 MG Oral TabletSCD07ad4366-4b21-f633-49f3-c2b35f88168d12
199247glimepiride 4 MG Oral TabletSCD07ad4366-4b21-f633-49f3-c2b35f88168d12
199245glimepiride 1 MG Oral TabletPSN0003458f-352a-46fa-9d99-230daa76ae2911
199246glimepiride 2 MG Oral TabletPSN0003458f-352a-46fa-9d99-230daa76ae2911
199247glimepiride 4 MG Oral TabletPSN0003458f-352a-46fa-9d99-230daa76ae2911
199245glimepiride 1 MG Oral TabletSCD0003458f-352a-46fa-9d99-230daa76ae2911
199246glimepiride 2 MG Oral TabletSCD0003458f-352a-46fa-9d99-230daa76ae2911
199247glimepiride 4 MG Oral TabletSCD0003458f-352a-46fa-9d99-230daa76ae2911
199245glimepiride 1 MG Oral TabletPSN93f1e064-fcbd-e8fd-e053-2995a90a5dbb5
199246glimepiride 2 MG Oral TabletPSN93f1e064-fcbd-e8fd-e053-2995a90a5dbb5
199247glimepiride 4 MG Oral TabletPSN93f1e064-fcbd-e8fd-e053-2995a90a5dbb5
199245glimepiride 1 MG Oral TabletSCD93f1e064-fcbd-e8fd-e053-2995a90a5dbb5
199246glimepiride 2 MG Oral TabletSCD93f1e064-fcbd-e8fd-e053-2995a90a5dbb5
199247glimepiride 4 MG Oral TabletSCD93f1e064-fcbd-e8fd-e053-2995a90a5dbb5
199245glimepiride 1 MG Oral TabletPSN3b20ae5e-9807-46c2-9de1-b64e76e617302
199246glimepiride 2 MG Oral TabletPSN3b20ae5e-9807-46c2-9de1-b64e76e617302
199247glimepiride 4 MG Oral TabletPSN3b20ae5e-9807-46c2-9de1-b64e76e617302
199245glimepiride 1 MG Oral TabletSCD3b20ae5e-9807-46c2-9de1-b64e76e617302
199246glimepiride 2 MG Oral TabletSCD3b20ae5e-9807-46c2-9de1-b64e76e617302
199247glimepiride 4 MG Oral TabletSCD3b20ae5e-9807-46c2-9de1-b64e76e617302
199245glimepiride 1 MG Oral TabletPSN1f102e4c-1954-4f17-8c60-4dad79f25a251
199245glimepiride 1 MG Oral TabletSCD1f102e4c-1954-4f17-8c60-4dad79f25a251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-320-0155111032001100 TABLET in 1 BOTTLE (55111-320-01) 100 tablet2005-10-060000-00-00NoNoCurrent
55111-320-0555111032005500 TABLET in 1 BOTTLE (55111-320-05) 500 tablet2005-10-060000-00-00NoNoCurrent
55111-320-305511103203030 TABLET in 1 BOTTLE (55111-320-30) 30 tablet2005-10-060000-00-00NoNoCurrent
55111-320-7855111032078100 BLISTER PACK in 1 CARTON (55111-320-78) / 1 TABLET in 1 BLISTER PACK (55111-320-79) 100 blister pack2005-10-060000-00-00NoNoCurrent
55111-320-79551110320791 in 1 BLISTER PACKHistorical