FDA.reportPublic FDA data

pioglitazone and glimepiride

Product NDC
66993-822
11-digit product format
669930822
Labeler code
66993
Product ID
66993-822_370e643e-7cf8-4a0a-b6c4-78e96162c48f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pioglitazone and glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Prasco Laboratories
Application
NDA021925
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-08-04
Substance
GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE
Active strength
4; 30 mg/1; mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Sulfonylurea Compounds [CS], Sulfonylurea [EPC], Thiazolidinedione [EPC], Thiazolidinediones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
pioglitazone and glimepiride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIMEPIRIDE4 mg/1
PIOGLITAZONE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJQT35NPK6C, 6KY687524K
Rxcui647237, 647239

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e11f0f31-8914-938f-521e-037b6de27c13Product name520210621
b890b964-2cf0-4439-aaf3-900c9e3e9e49Product name120160602
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
ac29cd77-922c-d25a-f8ad-66a8692935c5Product name120140508
d36d861f-8a90-80cc-8935-1e6be9b4c7ebProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66993-822-30pioglitazone and glimepiride30 in 1 BOTTLETABLET309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-822-30EA - Each66993-822f3a451e5-49fc-4680-b844-7b63740127c612015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
glimepirideACTIVE INGREDIENT6KY687524KPIOGLITAZONE AND GLIMEPIRIDE TABLET [PRASCO LABORATORIES]1
pioglitazone hydrochlorideACTIVE INGREDIENTJQT35NPK6CPIOGLITAZONE AND GLIMEPIRIDE TABLET [PRASCO LABORATORIES]1
glimepirideACTIVE MOIETY6KY687524KPIOGLITAZONE AND GLIMEPIRIDE TABLET [PRASCO LABORATORIES]1
pioglitazoneACTIVE MOIETYX4OV71U42SPIOGLITAZONE AND GLIMEPIRIDE TABLET [PRASCO LABORATORIES]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UPIOGLITAZONE AND GLIMEPIRIDE TABLET [PRASCO LABORATORIES]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48PIOGLITAZONE AND GLIMEPIRIDE TABLET [PRASCO LABORATORIES]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPIOGLITAZONE AND GLIMEPIRIDE TABLET [PRASCO LABORATORIES]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPIOGLITAZONE AND GLIMEPIRIDE TABLET [PRASCO LABORATORIES]1
magnesium stearateINACTIVE INGREDIENT70097M6I30PIOGLITAZONE AND GLIMEPIRIDE TABLET [PRASCO LABORATORIES]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPIOGLITAZONE AND GLIMEPIRIDE TABLET [PRASCO LABORATORIES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-822PIOGLITAZONE AND GLIMEPIRIDE TABLET [PRASCO LABORATORIES]8Current NDC, Legacy NDC, 1 package rows20211218_ea385b3d-cb4c-4550-97b0-93a86533f6dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
647237pioglitazone HCl 30 MG / glimepiride 2 MG Oral TabletPSNea385b3d-cb4c-4550-97b0-93a86533f6dc9
647239pioglitazone HCl 30 MG / glimepiride 4 MG Oral TabletPSNea385b3d-cb4c-4550-97b0-93a86533f6dc9
647237glimepiride 2 MG / pioglitazone 30 MG Oral TabletSCDea385b3d-cb4c-4550-97b0-93a86533f6dc9
647239glimepiride 4 MG / pioglitazone 30 MG Oral TabletSCDea385b3d-cb4c-4550-97b0-93a86533f6dc9
647237glimepiride 2 MG / pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSYea385b3d-cb4c-4550-97b0-93a86533f6dc9
647239glimepiride 4 MG / pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSYea385b3d-cb4c-4550-97b0-93a86533f6dc9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66993-822-306699308223030 TABLET in 1 BOTTLE (66993-822-30) 30 tablet2015-08-040000-00-00NoNoCurrent