FDA.reportPublic FDA data

METFORMIN HYDROCHLORIDE

Product NDC
43353-987
11-digit product format
433530987
Labeler code
43353
Product ID
43353-987_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
1000 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 HYDROCHLORIDE1000 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
43353-987-30METFORMIN HYDROCHLORIDE30 in 1 BOTTLETABLET306
43353-987-31METFORMIN HYDROCHLORIDE600 in 1 BOTTLETABLET6006
43353-987-43METFORMIN HYDROCHLORIDE1300 in 1 BOTTLETABLET13006
43353-987-45METFORMIN HYDROCHLORIDE45 in 1 BOTTLETABLET456
43353-987-53METFORMIN HYDROCHLORIDE60 in 1 BOTTLETABLET606
43353-987-60METFORMIN HYDROCHLORIDE90 in 1 BOTTLETABLET906
43353-987-73METFORMIN HYDROCHLORIDE135 in 1 BOTTLETABLET1356
43353-987-80METFORMIN HYDROCHLORIDE180 in 1 BOTTLETABLET1806
43353-987-86METFORMIN HYDROCHLORIDE225 in 1 BOTTLETABLET2256
43353-987-87METFORMIN HYDROCHLORIDE2400 in 1 BOTTLETABLET24006
43353-987-96METFORMIN HYDROCHLORIDE450 in 1 BOTTLETABLET4506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-987-30EA - Each43353-98794c193cc-6da4-44c5-bba6-8a64dd2edf6c12016-07-19
43353-987-31EA - Each43353-987184842c5-be48-435c-a956-f47847284b0412024-08-12
43353-987-43EA - Each43353-987f86b0bba-63cd-4954-9edf-93b1148809d312024-08-12
43353-987-45EA - Each43353-987ef2a647f-6b6b-461b-9693-32fd1539182f12016-07-19
43353-987-53EA - Each43353-987b57de7b5-33c0-4abe-b63c-675fd455ec2912016-07-19
43353-987-60EA - Each43353-9878a9df6ca-8e2d-4903-946c-7abe672b7a9e12016-07-19
43353-987-73EA - Each43353-987a5fa460a-3712-4aeb-a92a-ed939aa8f3a812016-07-19
43353-987-80EA - Each43353-9879a8ad0d4-e2f5-4006-8f7a-c2bf7db337bd12016-07-19
43353-987-86EA - Each43353-9879f2742ec-ffd8-4f98-bef3-d6c269e7977e12016-07-19
43353-987-87EA - Each43353-9878e9f4fa2-ae31-4d4f-aa8a-029b8e3321f712024-08-12
43353-987-96EA - Each43353-98715056e42-30bd-4c76-8988-fbdcfc3f77b012020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-987METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]5Current NDC, Legacy NDC, 11 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
43353-987-304335309873030 TABLET in 1 BOTTLE (43353-987-30) 30 tablet2014-12-220000-00-00NoNoCurrent
43353-987-3143353098731600 TABLET in 1 BOTTLE (43353-987-31) 600 tablet2024-06-10NoNoCurrent
43353-987-43433530987431300 TABLET in 1 BOTTLE (43353-987-43) 1300 tablet2024-06-10NoNoCurrent
43353-987-454335309874545 TABLET in 1 BOTTLE (43353-987-45) 45 tablet2015-01-050000-00-00NoNoCurrent
43353-987-534335309875360 TABLET in 1 BOTTLE (43353-987-53) 60 tablet2015-02-240000-00-00NoNoCurrent
43353-987-604335309876090 TABLET in 1 BOTTLE (43353-987-60) 90 tablet2015-02-020000-00-00NoNoCurrent
43353-987-7343353098773135 TABLET in 1 BOTTLE (43353-987-73) 135 tablet2014-12-210000-00-00NoNoCurrent
43353-987-8043353098780180 TABLET in 1 BOTTLE (43353-987-80) 180 tablet2016-02-020000-00-00NoNoCurrent
43353-987-8643353098786225 TABLET in 1 BOTTLE (43353-987-86) 225 tablet2014-12-220000-00-00NoNoCurrent
43353-987-87433530987872400 TABLET in 1 BOTTLE (43353-987-87) 2400 tablet2024-06-10NoNoCurrent
43353-987-9643353098796450 TABLET in 1 BOTTLE (43353-987-96) 450 tablet2020-05-130000-00-00NoNoCurrent