FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
12634-757
11-digit product format
126340757
Labeler code
12634
Product ID
12634-757_46625c1e-8ee1-4178-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA091184
Marketing category
ANDA
Marketing start
2011-01-31
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
850 mg/1
Pharmacologic classes
Biguanide [EPC],Biguanides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
12634-757-002022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-012022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-092022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-122022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-182022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-402022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-422022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-452022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-502022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-522022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-542022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-572022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-592022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-602022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-612022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-632022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-662022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-672022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-692022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-712022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-742022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-782022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-792022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-802022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-812022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-822022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-842022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-852022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-902022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-912022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-922022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-932022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-942022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-952022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-962022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-972022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-982022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP
12634-757-992022-07-29C16284748780-1e4f33bdf-a4fd-d8a0-e053-dadaa90a6e4eMetformin Hydrochloride Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-757-00Metformin Hydrochloride10 in 1 BOTTLETABLET, FILM COATED102
12634-757-01Metformin Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1002
12634-757-09Metformin Hydrochloride35 in 1 BOTTLETABLET, FILM COATED352
12634-757-12Metformin Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1202
12634-757-18Metformin Hydrochloride180 in 1 BOTTLETABLET, FILM COATED1802
12634-757-40Metformin Hydrochloride40 in 1 BOTTLETABLET, FILM COATED402
12634-757-42Metformin Hydrochloride42 in 1 BOTTLETABLET, FILM COATED422
12634-757-45Metformin Hydrochloride45 in 1 BOTTLETABLET, FILM COATED452
12634-757-50Metformin Hydrochloride50 in 1 BOTTLETABLET, FILM COATED502
12634-757-52Metformin Hydrochloride12 in 1 BLISTER PACKTABLET, FILM COATED122
12634-757-54Metformin Hydrochloride14 in 1 BLISTER PACKTABLET, FILM COATED142
12634-757-57Metformin Hydrochloride20 in 1 BLISTER PACKTABLET, FILM COATED202
12634-757-59Metformin Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED302
12634-757-60Metformin Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
12634-757-61Metformin Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED102
12634-757-63Metformin Hydrochloride3 in 1 BLISTER PACKTABLET, FILM COATED32
12634-757-66Metformin Hydrochloride6 in 1 BLISTER PACKTABLET, FILM COATED62
12634-757-67Metformin Hydrochloride7 in 1 BLISTER PACKTABLET, FILM COATED72
12634-757-69Metformin Hydrochloride9 in 1 BLISTER PACKTABLET, FILM COATED92
12634-757-71Metformin Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
12634-757-74Metformin Hydrochloride24 in 1 BOTTLETABLET, FILM COATED242
12634-757-78Metformin Hydrochloride28 in 1 BOTTLETABLET, FILM COATED282
12634-757-79Metformin Hydrochloride25 in 1 BOTTLETABLET, FILM COATED252
12634-757-80Metformin Hydrochloride20 in 1 BOTTLETABLET, FILM COATED202
12634-757-81Metformin Hydrochloride21 in 1 BOTTLETABLET, FILM COATED212
12634-757-82Metformin Hydrochloride12 in 1 BOTTLETABLET, FILM COATED122
12634-757-84Metformin Hydrochloride14 in 1 BOTTLETABLET, FILM COATED142
12634-757-85Metformin Hydrochloride15 in 1 BOTTLETABLET, FILM COATED152
12634-757-90Metformin Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902
12634-757-91Metformin Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED12
12634-757-92Metformin Hydrochloride2 in 1 BOTTLETABLET, FILM COATED22
12634-757-93Metformin Hydrochloride3 in 1 BOTTLETABLET, FILM COATED32
12634-757-94Metformin Hydrochloride4 in 1 BOTTLETABLET, FILM COATED42
12634-757-95Metformin Hydrochloride5 in 1 BOTTLETABLET, FILM COATED52
12634-757-96Metformin Hydrochloride6 in 1 BOTTLETABLET, FILM COATED62
12634-757-97Metformin Hydrochloride7 in 1 BOTTLETABLET, FILM COATED72
12634-757-98Metformin Hydrochloride8 in 1 BOTTLETABLET, FILM COATED82
12634-757-99Metformin Hydrochloride9 in 1 BOTTLETABLET, FILM COATED92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-757METFORMIN HYDROCHLORIDE TABLET, FILM COATED [APOTHECA INC.]2Legacy NDC, 38 package rows20170118_4661d307-78b2-2f5b-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSN4661d307-78b2-2f5b-e054-00144ff88e882
861007metFORMIN HCl 500 MG Oral TabletPSN4661d307-78b2-2f5b-e054-00144ff88e882
861010metFORMIN HCl 850 MG Oral TabletPSN4661d307-78b2-2f5b-e054-00144ff88e882
861004metformin hydrochloride 1000 MG Oral TabletSCD4661d307-78b2-2f5b-e054-00144ff88e882
861007metformin hydrochloride 500 MG Oral TabletSCD4661d307-78b2-2f5b-e054-00144ff88e882
861010metformin hydrochloride 850 MG Oral TabletSCD4661d307-78b2-2f5b-e054-00144ff88e882
861004metformin HCl 1 GM Oral TabletSY4661d307-78b2-2f5b-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
12634-757-001263407570010 TABLET, FILM COATED in 1 BOTTLE (12634-757-00) 2011-01-310000-00-00NoNoCurrent
12634-757-0112634075701100 TABLET, FILM COATED in 1 BOTTLE (12634-757-01) 2011-01-310000-00-00NoNoCurrent
12634-757-091263407570935 TABLET, FILM COATED in 1 BOTTLE (12634-757-09) 2011-01-310000-00-00NoNoCurrent
12634-757-1212634075712120 TABLET, FILM COATED in 1 BOTTLE (12634-757-12) 2011-01-310000-00-00NoNoCurrent
12634-757-1812634075718180 TABLET, FILM COATED in 1 BOTTLE (12634-757-18) 2011-01-310000-00-00NoNoCurrent
12634-757-401263407574040 TABLET, FILM COATED in 1 BOTTLE (12634-757-40) 2011-01-310000-00-00NoNoCurrent
12634-757-421263407574242 TABLET, FILM COATED in 1 BOTTLE (12634-757-42) 2011-01-310000-00-00NoNoCurrent
12634-757-451263407574545 TABLET, FILM COATED in 1 BOTTLE (12634-757-45) 2011-01-310000-00-00NoNoCurrent
12634-757-501263407575050 TABLET, FILM COATED in 1 BOTTLE (12634-757-50) 2011-01-310000-00-00NoNoCurrent
12634-757-521263407575212 TABLET, FILM COATED in 1 BLISTER PACK (12634-757-52) 2011-01-310000-00-00NoNoCurrent
12634-757-541263407575414 TABLET, FILM COATED in 1 BLISTER PACK (12634-757-54) 2011-01-310000-00-00NoNoCurrent
12634-757-571263407575720 TABLET, FILM COATED in 1 BLISTER PACK (12634-757-57) 2011-01-310000-00-00NoNoCurrent
12634-757-591263407575930 TABLET, FILM COATED in 1 BLISTER PACK (12634-757-59) 2011-01-310000-00-00NoNoCurrent
12634-757-601263407576060 TABLET, FILM COATED in 1 BOTTLE (12634-757-60) 2011-01-310000-00-00NoNoCurrent
12634-757-611263407576110 TABLET, FILM COATED in 1 BLISTER PACK (12634-757-61) 2011-01-310000-00-00NoNoCurrent
12634-757-63126340757633 TABLET, FILM COATED in 1 BLISTER PACK (12634-757-63) 2011-01-310000-00-00NoNoCurrent
12634-757-66126340757666 TABLET, FILM COATED in 1 BLISTER PACK (12634-757-66) 2011-01-310000-00-00NoNoCurrent
12634-757-67126340757677 TABLET, FILM COATED in 1 BLISTER PACK (12634-757-67) 2011-01-310000-00-00NoNoCurrent
12634-757-69126340757699 TABLET, FILM COATED in 1 BLISTER PACK (12634-757-69) 2011-01-310000-00-00NoNoCurrent
12634-757-711263407577130 TABLET, FILM COATED in 1 BOTTLE (12634-757-71) 2011-01-310000-00-00NoNoCurrent
12634-757-741263407577424 TABLET, FILM COATED in 1 BOTTLE (12634-757-74) 2011-01-310000-00-00NoNoCurrent
12634-757-781263407577828 TABLET, FILM COATED in 1 BOTTLE (12634-757-78) 2011-01-310000-00-00NoNoCurrent
12634-757-791263407577925 TABLET, FILM COATED in 1 BOTTLE (12634-757-79) 2011-01-310000-00-00NoNoCurrent
12634-757-801263407578020 TABLET, FILM COATED in 1 BOTTLE (12634-757-80) 2011-01-310000-00-00NoNoCurrent
12634-757-811263407578121 TABLET, FILM COATED in 1 BOTTLE (12634-757-81) 2011-01-310000-00-00NoNoCurrent
12634-757-821263407578212 TABLET, FILM COATED in 1 BOTTLE (12634-757-82) 2011-01-310000-00-00NoNoCurrent
12634-757-841263407578414 TABLET, FILM COATED in 1 BOTTLE (12634-757-84) 2011-01-310000-00-00NoNoCurrent
12634-757-851263407578515 TABLET, FILM COATED in 1 BOTTLE (12634-757-85) 2011-01-310000-00-00NoNoCurrent
12634-757-901263407579090 TABLET, FILM COATED in 1 BOTTLE (12634-757-90) 2011-01-310000-00-00NoNoCurrent
12634-757-91126340757911 TABLET, FILM COATED in 1 BLISTER PACK (12634-757-91) 2011-01-310000-00-00NoNoCurrent
12634-757-92126340757922 TABLET, FILM COATED in 1 BOTTLE (12634-757-92) 2011-01-310000-00-00NoNoCurrent
12634-757-93126340757933 TABLET, FILM COATED in 1 BOTTLE (12634-757-93) 2011-01-310000-00-00NoNoCurrent
12634-757-94126340757944 TABLET, FILM COATED in 1 BOTTLE (12634-757-94) 2011-01-310000-00-00NoNoCurrent
12634-757-95126340757955 TABLET, FILM COATED in 1 BOTTLE (12634-757-95) 2011-01-310000-00-00NoNoCurrent
12634-757-96126340757966 TABLET, FILM COATED in 1 BOTTLE (12634-757-96) 2011-01-310000-00-00NoNoCurrent
12634-757-97126340757977 TABLET, FILM COATED in 1 BOTTLE (12634-757-97) 2011-01-310000-00-00NoNoCurrent
12634-757-98126340757988 TABLET, FILM COATED in 1 BOTTLE (12634-757-98) 2011-01-310000-00-00NoNoCurrent
12634-757-99126340757999 TABLET, FILM COATED in 1 BOTTLE (12634-757-99) 2011-01-310000-00-00NoNoCurrent