FORTAMET

Product NDC
59630-574
11-digit product format
596300574
Labeler code
59630
Product ID
59630-574_e45e2672-48e2-480a-8f08-252cfadbcaa4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metformin hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Shionogi Inc.
Application
NDA021574
Marketing category
NDA
Marketing start
2004-04-27
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59630-574-60EA - Each59630-574f5101fad-80e5-4eb6-a8e1-4e8b9a96360f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EFORTAMET (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
METFORMINACTIVE MOIETY9100L32L2NFORTAMET (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19FORTAMET (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6FORTAMET (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FORTAMET (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOFORTAMET (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FORTAMET (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AFORTAMET (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFORTAMET (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EFORTAMET (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFORTAMET (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFORTAMET (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673FORTAMET (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860998Fortamet 1000 MG 24HR Extended Release Oral TabletPSN8cbcee12-3eb1-4726-9212-5dddc39a3b0f1
861002Fortamet 500 MG 24HR Extended Release Oral TabletPSN8cbcee12-3eb1-4726-9212-5dddc39a3b0f1
1807894metFORMIN HCl 1000 MG Osmotic 24HR Extended Release Oral TabletPSN8cbcee12-3eb1-4726-9212-5dddc39a3b0f1
1807917metFORMIN HCl 500 MG Osmotic 24HR Extended Release Oral TabletPSN8cbcee12-3eb1-4726-9212-5dddc39a3b0f1
860998Osmotic 24 HR metformin hydrochloride 1000 MG Extended Release Oral Tablet [Fortamet]SBD8cbcee12-3eb1-4726-9212-5dddc39a3b0f1
861002Osmotic 24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet [Fortamet]SBD8cbcee12-3eb1-4726-9212-5dddc39a3b0f1
1807894Osmotic 24 HR metformin hydrochloride 1000 MG Extended Release Oral TabletSCD8cbcee12-3eb1-4726-9212-5dddc39a3b0f1
1807917Osmotic 24 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD8cbcee12-3eb1-4726-9212-5dddc39a3b0f1
860998Fortamet 1000 MG 24HR Extended Release Oral TabletSY8cbcee12-3eb1-4726-9212-5dddc39a3b0f1
861002Fortamet 500 MG 24HR Extended Release Oral TabletSY8cbcee12-3eb1-4726-9212-5dddc39a3b0f1
1807894metformin HCl 1000 MG Osmotic 24 HR Extended Release Oral TabletSY8cbcee12-3eb1-4726-9212-5dddc39a3b0f1
1807917metformin HCl 500 MG Osmotic 24HR Extended Release Oral TabletSY8cbcee12-3eb1-4726-9212-5dddc39a3b0f1
860998Osmotic 24 HR Fortamet 1000 MG Extended Release Oral TabletSY8cbcee12-3eb1-4726-9212-5dddc39a3b0f1
861002Osmotic 24 HR Fortamet 500 MG Extended Release Oral TabletSY8cbcee12-3eb1-4726-9212-5dddc39a3b0f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59630-574-605963005746060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59630-574-60) 2004-04-270000-00-00NoNoCurrent