METFORMIN HYDROCHLORIDE EXTENDED RELEASE

Product NDC
71335-0293
11-digit product format
713350293
Labeler code
71335
Product ID
71335-0293_1210ee1b-4a39-4f60-af08-02eeca33dfca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METFORMIN HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
METFORMIN HYDROCHLORIDE EXTENDED RELEASE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii786Z46389E
Rxcui860975

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
71335-0293-12025-03-28C16284748780-11030e365-690e-111a-e063-dadaa90a10e2METFORMIN ER TABLETS
71335-0293-22025-03-28C16284748780-11030e365-690e-111a-e063-dadaa90a10e2METFORMIN ER TABLETS
71335-0293-32025-03-28C16284748780-11030e365-690e-111a-e063-dadaa90a10e2METFORMIN ER TABLETS
71335-0293-42025-03-28C16284748780-11030e365-690e-111a-e063-dadaa90a10e2METFORMIN ER TABLETS
71335-0293-52025-03-28C16284748780-11030e365-690e-111a-e063-dadaa90a10e2METFORMIN ER TABLETS
71335-0293-62025-03-28C16284748780-11030e365-690e-111a-e063-dadaa90a10e2METFORMIN ER TABLETS
71335-0293-72025-03-28C16284748780-11030e365-690e-111a-e063-dadaa90a10e2METFORMIN ER TABLETS
71335-0293-82025-03-28C16284748780-11030e365-690e-111a-e063-dadaa90a10e2METFORMIN ER TABLETS
71335-0293-92025-03-28C16284748780-11030e365-690e-111a-e063-dadaa90a10e2METFORMIN ER TABLETS
71335-0293-12024-01-30C16284748780-11030e365-690e-111a-e063-dadaa90a10e2METFORMIN ER TABLETS
71335-0293-22024-01-30C16284748780-11030e365-690e-111a-e063-dadaa90a10e2METFORMIN ER TABLETS
71335-0293-32024-01-30C16284748780-11030e365-690e-111a-e063-dadaa90a10e2METFORMIN ER TABLETS
71335-0293-42024-01-30C16284748780-11030e365-690e-111a-e063-dadaa90a10e2METFORMIN ER TABLETS
71335-0293-52024-01-30C16284748780-11030e365-690e-111a-e063-dadaa90a10e2METFORMIN ER TABLETS
71335-0293-62024-01-30C16284748780-11030e365-690e-111a-e063-dadaa90a10e2METFORMIN ER TABLETS
71335-0293-72024-01-30C16284748780-11030e365-690e-111a-e063-dadaa90a10e2METFORMIN ER TABLETS
71335-0293-82024-01-30C16284748780-11030e365-690e-111a-e063-dadaa90a10e2METFORMIN ER TABLETS
71335-0293-92024-01-30C16284748780-11030e365-690e-111a-e063-dadaa90a10e2METFORMIN ER TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0293-1METFORMIN HYDROCHLORIDE EXTENDED RELEASE60 in 1 BOTTLETABLET, EXTENDED RELEASE609
71335-0293-2METFORMIN HYDROCHLORIDE EXTENDED RELEASE30 in 1 BOTTLETABLET, EXTENDED RELEASE309
71335-0293-3METFORMIN HYDROCHLORIDE EXTENDED RELEASE100 in 1 BOTTLETABLET, EXTENDED RELEASE1009
71335-0293-4METFORMIN HYDROCHLORIDE EXTENDED RELEASE90 in 1 BOTTLETABLET, EXTENDED RELEASE909
71335-0293-5METFORMIN HYDROCHLORIDE EXTENDED RELEASE120 in 1 BOTTLETABLET, EXTENDED RELEASE1209
71335-0293-6METFORMIN HYDROCHLORIDE EXTENDED RELEASE15 in 1 BOTTLETABLET, EXTENDED RELEASE159
71335-0293-7METFORMIN HYDROCHLORIDE EXTENDED RELEASE45 in 1 BOTTLETABLET, EXTENDED RELEASE459
71335-0293-8METFORMIN HYDROCHLORIDE EXTENDED RELEASE180 in 1 BOTTLETABLET, EXTENDED RELEASE1809
71335-0293-9METFORMIN HYDROCHLORIDE EXTENDED RELEASE20 in 1 BOTTLETABLET, EXTENDED RELEASE209

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0293-1EA - Each71335-02934aa9a7dc-acf9-41e9-8b61-4c79ecdfea4612018-01-12
71335-0293-2EA - Each71335-029395a37ba4-6b68-4a93-9018-e4016225bbb012018-01-12
71335-0293-3EA - Each71335-029388b2979c-b64c-4a40-ab1f-813b0a7782ce12018-01-12
71335-0293-4EA - Each71335-02939ac1f7cc-201e-4110-b0de-edcfbb199e8712018-01-12
71335-0293-5EA - Each71335-02931b4d263e-078d-4103-b610-1c4e29f98b4e12018-01-12
71335-0293-6EA - Each71335-02931da52f7b-a04d-41be-8fad-a2f87ddee13112018-01-12
71335-0293-7EA - Each71335-02936cace211-30d9-4438-9e58-e3cb8004cf9d12018-01-12
71335-0293-8EA - Each71335-0293001428e5-6d9b-490f-867f-9291c68a123212018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0293METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 9 package rows20250331_3e55944a-ed5b-4892-804f-abbe15b0d70c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0293-17133502930160 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0293-1) 2018-03-190000-00-00NoNoCurrent
71335-0293-27133502930230 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0293-2) 2018-10-300000-00-00NoNoCurrent
71335-0293-371335029303100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0293-3) 2019-08-190000-00-00NoNoCurrent
71335-0293-47133502930490 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0293-4) 2018-03-020000-00-00NoNoCurrent
71335-0293-571335029305120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0293-5) 2018-03-230000-00-00NoNoCurrent
71335-0293-67133502930615 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0293-6) 2018-02-140000-00-00NoNoCurrent
71335-0293-77133502930745 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0293-7) 2022-02-230000-00-00NoNoCurrent
71335-0293-871335029308180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0293-8) 2018-02-160000-00-00NoNoCurrent
71335-0293-97133502930920 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0293-9) 2022-02-230000-00-00NoNoCurrent