FDA.reportPublic FDA data

ZITUVIMET XR

Product NDC
70710-1805
11-digit product format
707101805
Labeler code
70710
Product ID
70710-1805_506adfe0-80b4-4a62-9b2c-39bb23b04254
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sitagliptin and metformin hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
NDA216778
Marketing category
NDA
Marketing start
2024-10-31
Substance
METFORMIN HYDROCHLORIDE; SITAGLIPTIN
Active strength
1000; 50 mg/1; mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZITUVIMET XR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE1000 mg/1
SITAGLIPTIN50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQFP0P1DV7Z, 786Z46389E
Rxcui1243827, 1243842, 1243846, 2696282, 2696284, 2696287

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a29d87d-f465-752d-5fa9-bd728c608ca2Product name420251215
19a549d9-1cb9-4833-ba02-91db3dcb07baProduct name120251107
f6d21fb1-2c09-48ab-8d89-eeadf5a9698eProduct name120250724
ff2e6e82-af62-4b84-b1ca-09520f6c5a79Product name120250630
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
fd232072-39c4-4416-9b66-265d18a7bd93Product 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
9fa860f8-41a8-caa8-93ae-a5bdc7b15db7Product name120140508
ce63c1f8-ba50-8a17-9290-94522d75daffProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1805-6ZITUVIMET XR60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1805ZITUVIMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]1Current NDC, 1 package rows20241101_2f635b36-e86a-4e53-8eaf-589917b5f342.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243827SITagliptin 100 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSN2f635b36-e86a-4e53-8eaf-589917b5f3422
1243842SITagliptin 50 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSN2f635b36-e86a-4e53-8eaf-589917b5f3422
1243846SITagliptin 50 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN2f635b36-e86a-4e53-8eaf-589917b5f3422
2696287Zituvimet XR 100 MG / 1000 MG 24HR Extended Release Oral TabletPSN2f635b36-e86a-4e53-8eaf-589917b5f3422
2696282Zituvimet XR 50 MG / 1000 MG 24HR Extended Release Oral TabletPSN2f635b36-e86a-4e53-8eaf-589917b5f3422
2696284Zituvimet XR 50 MG / 500 MG 24HR Extended Release Oral TabletPSN2f635b36-e86a-4e53-8eaf-589917b5f3422
269628724 HR metformin hydrochloride 1000 MG / sitagliptin 100 MG Extended Release Oral Tablet [Zituvimet]SBD2f635b36-e86a-4e53-8eaf-589917b5f3422
269628224 HR metformin hydrochloride 1000 MG / sitagliptin 50 MG Extended Release Oral Tablet [Zituvimet]SBD2f635b36-e86a-4e53-8eaf-589917b5f3422
269628424 HR metformin hydrochloride 500 MG / sitagliptin 50 MG Extended Release Oral Tablet [Zituvimet]SBD2f635b36-e86a-4e53-8eaf-589917b5f3422
124382724 HR metformin hydrochloride 1000 MG / sitagliptin 100 MG Extended Release Oral TabletSCD2f635b36-e86a-4e53-8eaf-589917b5f3422
124384224 HR metformin hydrochloride 1000 MG / sitagliptin 50 MG Extended Release Oral TabletSCD2f635b36-e86a-4e53-8eaf-589917b5f3422
124384624 HR metformin hydrochloride 500 MG / sitagliptin 50 MG Extended Release Oral TabletSCD2f635b36-e86a-4e53-8eaf-589917b5f3422
1243827metformin hydrochloride 1000 MG / sitagliptin 100 MG 24 HR Extended Release Oral TabletSY2f635b36-e86a-4e53-8eaf-589917b5f3422
1243842metformin hydrochloride 1000 MG / sitagliptin 50 MG 24 HR Extended Release Oral TabletSY2f635b36-e86a-4e53-8eaf-589917b5f3422
1243846metformin hydrochloride 500 MG / sitagliptin (as sitagliptin phosphate) 50 MG 24 HR Extended Release Oral TabletSY2f635b36-e86a-4e53-8eaf-589917b5f3422
2696287Zituvimet XR 100/1000 24 HR Extended Release Oral TabletSY2f635b36-e86a-4e53-8eaf-589917b5f3422
2696282Zituvimet XR 50/1000 24 HR Extended Release Oral TabletSY2f635b36-e86a-4e53-8eaf-589917b5f3422
2696284Zituvimet XR 50/500 24 HR Extended Release Oral TabletSY2f635b36-e86a-4e53-8eaf-589917b5f3422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70710-1805-67071018050660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70710-1805-6) 2024-10-31NoNoCurrent