FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
67877-413
11-digit product format
678770413
Labeler code
67877
Product ID
67877-413_4fa6bd66-7f2c-4b63-9809-be460cbc2527
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA206145
Marketing category
ANDA
Marketing start
2018-10-27
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
Metformin Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii786Z46389E
Rxcui860975, 860981, 861004, 861007, 861010

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
67877-413-01Metformin Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE10024
67877-413-05Metformin Hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE50024
67877-413-10Metformin Hydrochloride1000 in 1 BOTTLETABLET, EXTENDED RELEASE100024
67877-413-33Metformin Hydrochloride10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1024
67877-413-33Metformin Hydrochloride10 in 1 CARTONTABLET, EXTENDED RELEASE1024
67877-413-90Metformin Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE9024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-413-01EA - Each67877-413bb3d90fb-2bc9-48a9-aab7-726bc89e23b512019-09-05
67877-413-05EA - Each67877-4137e542c08-9ffe-4a89-ae9a-e1f886c876c712019-09-05
67877-413-90EA - Each67877-413d02d3c79-a177-4375-9a9c-58d1923a80fc12021-01-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]11
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]11
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]11
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]11
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]11
TALCINACTIVE INGREDIENT7SEV7J4R1UMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETFORMIN HYDROCHLORIDE TABLET, FILM COATED [ASCEND LABORATORIES, LLC]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-413METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ASCEND LABORATORIES, LLC]23Current NDC, Legacy NDC, 6 package rows20231101_0ff1ba75-3c86-4baf-a6b1-1bb883839866.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSN0ff1ba75-3c86-4baf-a6b1-1bb88383986624
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN0ff1ba75-3c86-4baf-a6b1-1bb88383986624
861007metFORMIN HCl 500 MG Oral TabletPSN0ff1ba75-3c86-4baf-a6b1-1bb88383986624
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSN0ff1ba75-3c86-4baf-a6b1-1bb88383986624
861010metFORMIN HCl 850 MG Oral TabletPSN0ff1ba75-3c86-4baf-a6b1-1bb88383986624
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD0ff1ba75-3c86-4baf-a6b1-1bb88383986624
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCD0ff1ba75-3c86-4baf-a6b1-1bb88383986624
861004metformin hydrochloride 1000 MG Oral TabletSCD0ff1ba75-3c86-4baf-a6b1-1bb88383986624
861007metformin hydrochloride 500 MG Oral TabletSCD0ff1ba75-3c86-4baf-a6b1-1bb88383986624
861010metformin hydrochloride 850 MG Oral TabletSCD0ff1ba75-3c86-4baf-a6b1-1bb88383986624
861004metformin HCl 1 GM Oral TabletSY0ff1ba75-3c86-4baf-a6b1-1bb88383986624
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY0ff1ba75-3c86-4baf-a6b1-1bb88383986624
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSY0ff1ba75-3c86-4baf-a6b1-1bb88383986624
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNa57e2890-d83b-488c-b221-2e8f8a78ed1612
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDa57e2890-d83b-488c-b221-2e8f8a78ed1612
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYa57e2890-d83b-488c-b221-2e8f8a78ed1612
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNf5ef117c-27ff-c21e-e053-2995a90ae1455
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDf5ef117c-27ff-c21e-e053-2995a90ae1455
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYf5ef117c-27ff-c21e-e053-2995a90ae1455
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNd60139c2-fd35-4ab4-af7e-7410481edc2e4
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDd60139c2-fd35-4ab4-af7e-7410481edc2e4
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYd60139c2-fd35-4ab4-af7e-7410481edc2e4
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNe8937778-8bde-05f5-e053-2995a90a3a983
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDe8937778-8bde-05f5-e053-2995a90a3a983
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYe8937778-8bde-05f5-e053-2995a90a3a983
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN474e2900-43bf-4ebe-9d29-4a7adb8a94292
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD474e2900-43bf-4ebe-9d29-4a7adb8a94292
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY474e2900-43bf-4ebe-9d29-4a7adb8a94292
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN1e298db3-439e-4e91-8f9e-01c3cdc4d5521
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD1e298db3-439e-4e91-8f9e-01c3cdc4d5521
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY1e298db3-439e-4e91-8f9e-01c3cdc4d5521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-413-0167877041301100 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-413-01) 2018-10-270000-00-00NoNoCurrent
67877-413-0567877041305500 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-413-05) 2018-10-270000-00-00NoNoCurrent
67877-413-10678770413101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-413-10) 2018-10-270000-00-00NoNoCurrent
67877-413-336787704133310 BLISTER PACK in 1 CARTON (67877-413-33) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2018-10-270000-00-00NoNoCurrent
67877-413-906787704139090 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-413-90) 2019-12-270000-00-00NoNoCurrent