FDA.reportPublic FDA data

Glimepiride

Product NDC
55111-321
11-digit product format
551110321
Labeler code
55111
Product ID
55111-321_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
2 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
GLIMEPIRIDE2 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
55111-321-01Glimepiride100 in 1 BOTTLETABLET10012
55111-321-05Glimepiride500 in 1 BOTTLETABLET50012
55111-321-30Glimepiride30 in 1 BOTTLETABLET3012
55111-321-78Glimepiride100 in 1 CARTONTABLET10012
55111-321-79Glimepiride1 in 1 BLISTER PACKTABLET112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-321-01EA - Each55111-3214ccb283e-2c2a-40b8-897d-c82eb12b2fc512012-07-24
55111-321-05EA - Each55111-3210950104f-28ba-4991-a778-189463d3f58a12012-07-24

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 MOIETY6KY687524KGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]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
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
magnesium stearateINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
povidoneINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [BLENHEIM PHARMACAL, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [REBEL DISTRIBUTORS CORP]2
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [UNIT DOSE SERVICES]1
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [UNIT DOSE SERVICES]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [UNIT DOSE SERVICES]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLIMEPIRIDE TABLET [UNIT DOSE SERVICES]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLIMEPIRIDE TABLET [UNIT DOSE SERVICES]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [UNIT DOSE SERVICES]1
magnesium stearateINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [UNIT DOSE SERVICES]1
povidoneINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [UNIT DOSE SERVICES]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [UNIT DOSE SERVICES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-321GLIMEPIRIDE 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 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
199246glimepiride 2 MG Oral TabletPSNb5c912bf-d1b3-4c65-9049-0d91a382d23610
199246glimepiride 2 MG Oral TabletSCDb5c912bf-d1b3-4c65-9049-0d91a382d23610
199246glimepiride 2 MG Oral TabletPSNebb9f080-b11d-5d18-36f0-627107e7fbcd8
199246glimepiride 2 MG Oral TabletSCDebb9f080-b11d-5d18-36f0-627107e7fbcd8
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
199246glimepiride 2 MG Oral TabletPSNbe772fca-1579-4fba-a4b7-04b970d09e454
199246glimepiride 2 MG Oral TabletSCDbe772fca-1579-4fba-a4b7-04b970d09e454
199246glimepiride 2 MG Oral TabletPSN0a1eaf23-d5fd-4b3e-96c5-68ff16f0033b3
199246glimepiride 2 MG Oral TabletSCD0a1eaf23-d5fd-4b3e-96c5-68ff16f0033b3
199245glimepiride 1 MG Oral TabletPSN3b20ae5e-9807-46c2-9de1-b64e76e617302
199246glimepiride 2 MG Oral TabletPSN3b20ae5e-9807-46c2-9de1-b64e76e617302
199246glimepiride 2 MG Oral TabletPSNbf8e5993-5ee7-d26d-e053-2a95a90ae5df2
199246glimepiride 2 MG Oral TabletPSNdae404ac-881a-14d8-e053-2995a90acd412
199246glimepiride 2 MG Oral TabletPSNe2ed9eeb-e67d-485f-86cb-eb9061bd9d962
199247glimepiride 4 MG Oral TabletPSN3b20ae5e-9807-46c2-9de1-b64e76e617302
199247glimepiride 4 MG Oral TabletPSNe2ed9eeb-e67d-485f-86cb-eb9061bd9d962
199245glimepiride 1 MG Oral TabletSCD3b20ae5e-9807-46c2-9de1-b64e76e617302
199246glimepiride 2 MG Oral TabletSCD3b20ae5e-9807-46c2-9de1-b64e76e617302
199246glimepiride 2 MG Oral TabletSCDbf8e5993-5ee7-d26d-e053-2a95a90ae5df2
199246glimepiride 2 MG Oral TabletSCDdae404ac-881a-14d8-e053-2995a90acd412
199246glimepiride 2 MG Oral TabletSCDe2ed9eeb-e67d-485f-86cb-eb9061bd9d962
199247glimepiride 4 MG Oral TabletSCDe2ed9eeb-e67d-485f-86cb-eb9061bd9d962
199247glimepiride 4 MG Oral TabletSCD3b20ae5e-9807-46c2-9de1-b64e76e617302

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-321-0155111032101100 TABLET in 1 BOTTLE (55111-321-01) 100 tablet2005-10-060000-00-00NoNoCurrent
55111-321-0555111032105500 TABLET in 1 BOTTLE (55111-321-05) 500 tablet2005-10-060000-00-00NoNoCurrent
55111-321-305511103213030 TABLET in 1 BOTTLE (55111-321-30) 30 tablet2005-10-060000-00-00NoNoCurrent
55111-321-7855111032178100 BLISTER PACK in 1 CARTON (55111-321-78) / 1 TABLET in 1 BLISTER PACK (55111-321-79) 100 blister pack2005-10-060000-00-00NoNoCurrent
55111-321-79551110321791 in 1 BLISTER PACKHistorical