FDA.reportPublic FDA data

Metformin hydrochloride

Product NDC
67046-463
11-digit product format
670460463
Labeler code
67046
Product ID
67046-463_7e2b1ee0-b0af-f7c6-e053-2991aa0a47ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA090564
Marketing category
ANDA
Marketing start
2017-09-20
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
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
67046-463-072022-01-28C16284748780-1d6a99b39-4fea-a426-e053-dadaa90af4c2Metformin Hydrochloride Tablets USP 463 459 464
67046-463-142022-01-28C16284748780-1d6a99b39-4fea-a426-e053-dadaa90af4c2Metformin Hydrochloride Tablets USP 463 459 464
67046-463-152022-01-28C16284748780-1d6a99b39-4fea-a426-e053-dadaa90af4c2Metformin Hydrochloride Tablets USP 463 459 464
67046-463-202022-01-28C16284748780-1d6a99b39-4fea-a426-e053-dadaa90af4c2Metformin Hydrochloride Tablets USP 463 459 464
67046-463-212022-01-28C16284748780-1d6a99b39-4fea-a426-e053-dadaa90af4c2Metformin Hydrochloride Tablets USP 463 459 464
67046-463-282022-01-28C16284748780-1d6a99b39-4fea-a426-e053-dadaa90af4c2Metformin Hydrochloride Tablets USP 463 459 464
67046-463-302022-01-28C16284748780-1d6a99b39-4fea-a426-e053-dadaa90af4c2Metformin Hydrochloride Tablets USP 463 459 464
67046-463-602022-01-28C16284748780-1d6a99b39-4fea-a426-e053-dadaa90af4c2Metformin Hydrochloride Tablets USP 463 459 464

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-463-07Metformin hydrochloride7 in 1 BLISTER PACKTABLET73
67046-463-14Metformin hydrochloride14 in 1 BLISTER PACKTABLET143
67046-463-15Metformin hydrochloride15 in 1 BLISTER PACKTABLET153
67046-463-20Metformin hydrochloride20 in 1 BLISTER PACKTABLET203
67046-463-21Metformin hydrochloride21 in 1 BLISTER PACKTABLET213
67046-463-28Metformin hydrochloride28 in 1 BLISTER PACKTABLET283
67046-463-30Metformin hydrochloride30 in 1 BLISTER PACKTABLET303
67046-463-60Metformin hydrochloride60 in 1 BLISTER PACKTABLET603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-463METFORMIN HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]3Legacy NDC, 8 package rows20181230_59a485b1-8299-5d02-e053-2a91aa0a42e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSN59a485b1-8299-5d02-e053-2a91aa0a42e33
861007metFORMIN HCl 500 MG Oral TabletPSN59a485b1-8299-5d02-e053-2a91aa0a42e33
861010metFORMIN HCl 850 MG Oral TabletPSN59a485b1-8299-5d02-e053-2a91aa0a42e33
861004metformin hydrochloride 1000 MG Oral TabletSCD59a485b1-8299-5d02-e053-2a91aa0a42e33
861007metformin hydrochloride 500 MG Oral TabletSCD59a485b1-8299-5d02-e053-2a91aa0a42e33
861010metformin hydrochloride 850 MG Oral TabletSCD59a485b1-8299-5d02-e053-2a91aa0a42e33
861004metformin HCl 1 GM Oral TabletSY59a485b1-8299-5d02-e053-2a91aa0a42e33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-463-07670460463077 TABLET in 1 BLISTER PACK (67046-463-07) 7 tablet2017-09-200000-00-00NoNoCurrent
67046-463-146704604631414 TABLET in 1 BLISTER PACK (67046-463-14) 14 tablet2017-09-200000-00-00NoNoCurrent
67046-463-156704604631515 TABLET in 1 BLISTER PACK (67046-463-15) 15 tablet2017-09-200000-00-00NoNoCurrent
67046-463-206704604632020 TABLET in 1 BLISTER PACK (67046-463-20) 20 tablet2017-09-200000-00-00NoNoCurrent
67046-463-216704604632121 TABLET in 1 BLISTER PACK (67046-463-21) 21 tablet2017-09-200000-00-00NoNoCurrent
67046-463-286704604632828 TABLET in 1 BLISTER PACK (67046-463-28) 28 tablet2017-09-200000-00-00NoNoCurrent
67046-463-306704604633030 TABLET in 1 BLISTER PACK (67046-463-30) 30 tablet2017-09-200000-00-00NoNoCurrent
67046-463-606704604636060 TABLET in 1 BLISTER PACK (67046-463-60) 60 tablet2017-09-200000-00-00NoNoCurrent