FDA.reportPublic FDA data

METFORMIN HYDROCHLORIDE EXTENDED RELEASE

Product NDC
49483-623
11-digit product format
494830623
Labeler code
49483
Product ID
49483-623_4d845f5a-3ab1-b5ac-e063-6394a90a75d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
TIME CAP LABORATORIES, INC
Application
ANDA090295
Marketing category
ANDA
Marketing start
2016-05-12
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
METFORMIN HYDROCHLORIDE EXTENDED RELEASE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii786Z46389E
Rxcui860975, 860981

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49483-623-012025-02-10C16284748780-12cef2736-7d7b-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
49483-623-092025-02-10C16284748780-12cef2736-7d7b-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
49483-623-102025-02-10C16284748780-12cef2736-7d7b-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
49483-623-502025-02-10C16284748780-12cef2736-7d7b-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
49483-623-012025-01-30C16284748780-12cef2736-7d7b-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
49483-623-092025-01-30C16284748780-12cef2736-7d7b-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
49483-623-102025-01-30C16284748780-12cef2736-7d7b-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995
49483-623-502025-01-30C16284748780-12cef2736-7d7b-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49483-623-01METFORMIN HYDROCHLORIDE EXTENDED RELEASE100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE10010
49483-623-09METFORMIN HYDROCHLORIDE EXTENDED RELEASE90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE9010
49483-623-10METFORMIN HYDROCHLORIDE EXTENDED RELEASE1000 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE100010
49483-623-50METFORMIN HYDROCHLORIDE EXTENDED RELEASE500 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-623-01EA - Each49483-623d44d57e6-1b0b-4e9c-aab6-b3cba19b7a9012016-10-06
49483-623-09EA - Each49483-623a5375153-91cf-4c85-846b-b5457a1ec91112017-08-11
49483-623-10EA - Each49483-623800d903c-d568-470b-a1a5-25c6264379fd12017-08-11
49483-623-50EA - Each49483-623a03b6633-c6cc-4a55-afdb-e9176d64785512016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE E/R (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]2
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE E/R (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311METFORMIN HYDROCHLORIDE E/R (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HYDROCHLORIDE E/R (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HYDROCHLORIDE E/R (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECTRX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-623METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [TIME CAP LABORATORIES, INC]9Current NDC, Legacy NDC, 4 package rows20250212_1d8b8970-c2a1-4780-be87-ab8ccfd401fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN14f3091c-f243-4364-b433-727c7d4ef8d518
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD14f3091c-f243-4364-b433-727c7d4ef8d518
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY14f3091c-f243-4364-b433-727c7d4ef8d518
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN1d8b8970-c2a1-4780-be87-ab8ccfd401fa10
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSN1d8b8970-c2a1-4780-be87-ab8ccfd401fa10
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD1d8b8970-c2a1-4780-be87-ab8ccfd401fa10
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCD1d8b8970-c2a1-4780-be87-ab8ccfd401fa10
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY1d8b8970-c2a1-4780-be87-ab8ccfd401fa10
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSY1d8b8970-c2a1-4780-be87-ab8ccfd401fa10
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN3e55944a-ed5b-4892-804f-abbe15b0d70c9
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD3e55944a-ed5b-4892-804f-abbe15b0d70c9
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY3e55944a-ed5b-4892-804f-abbe15b0d70c9
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNa84cf1a3-3820-cd1b-e053-2995a90acf458
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDa84cf1a3-3820-cd1b-e053-2995a90acf458
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYa84cf1a3-3820-cd1b-e053-2995a90acf458
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN4a53ea53-3052-614b-e054-00144ff8d46c5
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD4a53ea53-3052-614b-e054-00144ff8d46c5
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY4a53ea53-3052-614b-e054-00144ff8d46c5
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNcc4f5988-cf23-4d6f-8108-5eb6ef8633a94
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDcc4f5988-cf23-4d6f-8108-5eb6ef8633a94
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYcc4f5988-cf23-4d6f-8108-5eb6ef8633a94
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN674bf07f-8123-1204-e053-2991aa0a73b42
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN179a4a21-1541-4f96-834f-e80731b62d922
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN0b843f12-a654-4751-be1f-55e6fce163c92
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD674bf07f-8123-1204-e053-2991aa0a73b42
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD179a4a21-1541-4f96-834f-e80731b62d922
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD0b843f12-a654-4751-be1f-55e6fce163c92
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY674bf07f-8123-1204-e053-2991aa0a73b42
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY179a4a21-1541-4f96-834f-e80731b62d922
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY0b843f12-a654-4751-be1f-55e6fce163c92
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN4e5a19c6-6ac6-ffc0-e063-6394a90a98271
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD4e5a19c6-6ac6-ffc0-e063-6394a90a98271
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY4e5a19c6-6ac6-ffc0-e063-6394a90a98271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49483-623-0149483062301100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-623-01) 2016-06-280000-00-00NoNoCurrent
49483-623-094948306230990 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-623-09) 2017-06-050000-00-00NoNoCurrent
49483-623-10494830623101000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-623-10) 2017-06-050000-00-00NoNoCurrent
49483-623-5049483062350500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-623-50) 2016-06-280000-00-00NoNoCurrent