GLYBURIDE AND METFORMIN HYDROCHLORIDE

Product NDC
55111-695
11-digit product format
551110695
Labeler code
55111
Product ID
55111-695_279b92ac-8e31-4b04-8983-6f161f5b709c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLYBURIDE AND METFORMIN HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA079009
Marketing category
ANDA
Marketing start
2009-06-30
Marketing end
0000-00-00
Substance
GLYBURIDE; METFORMIN HYDROCHLORIDE
Active strength
1 mg/1; mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS],Biguanide [EPC],Biguanides [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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ce63c1f8-ba50-8a17-9290-94522d75daffProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-695-01GLYBURIDE AND METFORMIN HYDROCHLORIDE100 in 1 BOTTLETABLET1002
55111-695-05GLYBURIDE AND METFORMIN HYDROCHLORIDE500 in 1 BOTTLETABLET5002
55111-695-10GLYBURIDE AND METFORMIN HYDROCHLORIDE1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-695-01EA - Each55111-695b122f643-7572-4b8d-b721-cc2ec7d5968112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYBURIDEACTIVE INGREDIENTSX6K58TVWCGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]2
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]2
GLYBURIDEACTIVE MOIETYSX6K58TVWCGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]2
METFORMINACTIVE MOIETY9100L32L2NGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]2
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]2
TALCINACTIVE INGREDIENT7SEV7J4R1UGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-695GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED]2Legacy NDC, 3 package rows20090701_89245260-c470-4a4c-8ef6-12598dc28e4c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861743glyBURIDE 1.25 MG / metFORMIN HCl 250 MG Oral TabletPSN89245260-c470-4a4c-8ef6-12598dc28e4c2
861748glyBURIDE 2.5 MG / metFORMIN HCl 500 MG Oral TabletPSN89245260-c470-4a4c-8ef6-12598dc28e4c2
861753glyBURIDE 5 MG / metFORMIN HCl 500 MG Oral TabletPSN89245260-c470-4a4c-8ef6-12598dc28e4c2
861743glyburide 1.25 MG / metformin hydrochloride 250 MG Oral TabletSCD89245260-c470-4a4c-8ef6-12598dc28e4c2
861748glyburide 2.5 MG / metformin hydrochloride 500 MG Oral TabletSCD89245260-c470-4a4c-8ef6-12598dc28e4c2
861753glyburide 5 MG / metformin hydrochloride 500 MG Oral TabletSCD89245260-c470-4a4c-8ef6-12598dc28e4c2
861753glyburide 5 MG / metformin HCl 500 MG Oral TabletSY89245260-c470-4a4c-8ef6-12598dc28e4c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55111-695-0155111069501100 in 1 BOTTLEHistorical
55111-695-0555111069505500 in 1 BOTTLEHistorical
55111-695-10551110695101000 in 1 BOTTLEHistorical