FDA.reportPublic FDA data

METFORMIN HYDROCHLORIDE

Product NDC
43353-982
11-digit product format
433530982
Labeler code
43353
Product ID
43353-982_4900492c-70fa-e5b5-e063-6294a90af743
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METFORMIN HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA203769
Marketing category
ANDA
Marketing start
2013-09-11
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii786Z46389E
Rxcui861004, 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
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
43353-982-30METFORMIN HYDROCHLORIDE30 in 1 BOTTLETABLET306
43353-982-53METFORMIN HYDROCHLORIDE60 in 1 BOTTLETABLET606
43353-982-60METFORMIN HYDROCHLORIDE90 in 1 BOTTLETABLET906
43353-982-70METFORMIN HYDROCHLORIDE120 in 1 BOTTLETABLET1206
43353-982-80METFORMIN HYDROCHLORIDE180 in 1 BOTTLETABLET1806
43353-982-92METFORMIN HYDROCHLORIDE270 in 1 BOTTLETABLET2706
43353-982-94METFORMIN HYDROCHLORIDE360 in 1 BOTTLETABLET3606
43353-982-96METFORMIN HYDROCHLORIDE450 in 1 BOTTLETABLET4506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-982-70EA - Each43353-982a8acab5b-4578-4019-8226-8a3f9d64c2e712024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-982METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]5Current NDC, Legacy NDC, 8 package rows20240618_273d86b0-9d30-48c9-8918-c5e1ececa951.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSN273d86b0-9d30-48c9-8918-c5e1ececa9516
861007metFORMIN HCl 500 MG Oral TabletPSN273d86b0-9d30-48c9-8918-c5e1ececa9516
861010metFORMIN HCl 850 MG Oral TabletPSN273d86b0-9d30-48c9-8918-c5e1ececa9516
861004metformin hydrochloride 1000 MG Oral TabletSCD273d86b0-9d30-48c9-8918-c5e1ececa9516
861007metformin hydrochloride 500 MG Oral TabletSCD273d86b0-9d30-48c9-8918-c5e1ececa9516
861010metformin hydrochloride 850 MG Oral TabletSCD273d86b0-9d30-48c9-8918-c5e1ececa9516
861004metformin HCl 1 GM Oral TabletSY273d86b0-9d30-48c9-8918-c5e1ececa9516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-982-304335309823030 TABLET in 1 BOTTLE (43353-982-30) 30 tablet2014-11-110000-00-00NoNoCurrent
43353-982-534335309825360 TABLET in 1 BOTTLE (43353-982-53) 60 tablet2015-11-160000-00-00NoNoCurrent
43353-982-604335309826090 TABLET in 1 BOTTLE (43353-982-60) 90 tablet2015-05-130000-00-00NoNoCurrent
43353-982-7043353098270120 TABLET in 1 BOTTLE (43353-982-70) 120 tablet2019-05-14NoNoCurrent
43353-982-8043353098280180 TABLET in 1 BOTTLE (43353-982-80) 180 tablet2015-05-120000-00-00NoNoCurrent
43353-982-9243353098292270 TABLET in 1 BOTTLE (43353-982-92) 270 tablet2015-05-120000-00-00NoNoCurrent
43353-982-9443353098294360 TABLET in 1 BOTTLE (43353-982-94) 360 tablet2015-05-120000-00-00NoNoCurrent
43353-982-9643353098296450 TABLET in 1 BOTTLE (43353-982-96) 450 tablet2015-03-280000-00-00NoNoCurrent