FDA.reportPublic FDA data

Glumetza

Product NDC
68012-004
11-digit product format
680120004
Labeler code
68012
Product ID
68012-004_41eb528d-e235-4563-833a-5cf36381d6db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metformin hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Santarus, Inc.
Application
NDA021748
Marketing category
NDA
Marketing start
2018-03-20
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Glumetza
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii786Z46389E
Rxcui861015, 861018, 1807888, 1807915

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a29d87d-f465-752d-5fa9-bd728c608ca2Product name420251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698eProduct name120250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5Product name720250515
25bfaa4d-02a1-402c-96ec-9bf6e625484cProduct name120250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0Product name220240829
16dbe107-66d5-47b3-57ed-0cba6a8dfcccProduct name620240215
08b3e508-8c7e-3b95-0275-113510642fc6Product name220220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8Product name120200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86Product name120200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
ca3f036c-6c06-b829-b379-1a3a4097099cProduct name920180605
e1ede89f-54c8-428f-ae84-9e8a2deb67dbProduct name120180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52cProduct name220170824
bea938a6-c880-985b-d27b-b59b0d8b5a77Product name320170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2fProduct name120170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cbProduct name120170224
988f737f-e7e9-4613-8558-824b1ab755f9Product name120161128
58b66776-50d5-434f-916f-958ccf131e0eProduct name120160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
2988466d-5fc4-4430-9cee-fc9132f02d2cProduct name120150910
85cbb42f-1a8d-f945-f85e-188e823b7f5bProduct name220150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7Product name120150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0Product name120141205
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6Product name120140508
2de6e143-c970-2061-1b77-61c3aa8f4026Product name120140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508
ce63c1f8-ba50-8a17-9290-94522d75daffProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68012-004-50Glumetza100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68012-004-50EA - Each68012-004904feb36-a1eb-4c12-9c4e-42151599264512018-07-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
metformin hydrochlorideACTIVE INGREDIENT786Z46389EGLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]6
metforminACTIVE MOIETY9100L32L2NGLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]6
crospovidoneINACTIVE INGREDIENT68401960MKGLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]6
glyceryl behenateINACTIVE INGREDIENTR8WTH25YS2GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]6
hypromellosesINACTIVE INGREDIENT3NXW29V3WOGLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]6
magnesium stearateINACTIVE INGREDIENT70097M6I30GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]6
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AGLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]6
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HGLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]6
polyvinyl alcoholINACTIVE INGREDIENT532B59J990GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]6
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]6
talcINACTIVE INGREDIENT7SEV7J4R1UGLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]6
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPGLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68012-004GLUMETZA (METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANTARUS, INC.]27Current NDC, Legacy NDC, 1 package rows20240328_fb832474-88d9-4e29-95cd-fbc446944cc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861015Glumetza 1000 MG 24HR Extended Release Oral TabletPSNfb832474-88d9-4e29-95cd-fbc446944cc430
861018Glumetza 500 MG Modified 24HR Extended Release Oral TabletPSNfb832474-88d9-4e29-95cd-fbc446944cc430
1807888metFORMIN HCl 1000 MG Modified 24HR Extended Release Oral TabletPSNfb832474-88d9-4e29-95cd-fbc446944cc430
1807915metFORMIN HCl 500 MG Modified 24HR Extended Release Oral TabletPSNfb832474-88d9-4e29-95cd-fbc446944cc430
861015Modified 24 HR metformin hydrochloride 1000 MG Extended Release Oral Tablet [Glumetza]SBDfb832474-88d9-4e29-95cd-fbc446944cc430
861018Modified 24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet [Glumetza]SBDfb832474-88d9-4e29-95cd-fbc446944cc430
1807888Modified 24 HR metformin hydrochloride 1000 MG Extended Release Oral TabletSCDfb832474-88d9-4e29-95cd-fbc446944cc430
1807915Modified 24 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDfb832474-88d9-4e29-95cd-fbc446944cc430
861015Glumetza 1000 MG 24HR Extended Release Oral TabletSYfb832474-88d9-4e29-95cd-fbc446944cc430
861018Glumetza 500 MG Modified 24 HR Extended Release Oral TabletSYfb832474-88d9-4e29-95cd-fbc446944cc430
1807888metformin HCl 1000 MG Modified 24 HR Extended Release Oral TabletSYfb832474-88d9-4e29-95cd-fbc446944cc430
1807915metformin HCl 500 MG Modified 24 HR Extended Release Oral TabletSYfb832474-88d9-4e29-95cd-fbc446944cc430
861015Modified 24 HR Glumetza 1000 MG Extended Release Oral TabletSYfb832474-88d9-4e29-95cd-fbc446944cc430

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68012-004-5068012000450100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-004-50) 2018-03-200000-00-00NoNoCurrent