FDA.reportPublic FDA data

METFORMIN HYDROCHLORIDE

Product NDC
71610-917
11-digit product format
716100917
Labeler code
71610
Product ID
71610-917_4ddf35bd-cab8-3f34-e063-6394a90a73ae
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
2015-02-01
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
Rxcui861007

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
71610-917-30METFORMIN HYDROCHLORIDE30 in 1 BOTTLETABLET302
71610-917-53METFORMIN HYDROCHLORIDE60 in 1 BOTTLETABLET602
71610-917-60METFORMIN HYDROCHLORIDE90 in 1 BOTTLETABLET902
71610-917-70METFORMIN HYDROCHLORIDE120 in 1 BOTTLETABLET1202
71610-917-80METFORMIN HYDROCHLORIDE180 in 1 BOTTLETABLET1802
71610-917-92METFORMIN HYDROCHLORIDE270 in 1 BOTTLETABLET2702
71610-917-94METFORMIN HYDROCHLORIDE360 in 1 BOTTLETABLET3602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-917-30EA - Each71610-91746c2a3af-bad0-4093-a0cc-359c6e4a5f4112025-08-11
71610-917-53EA - Each71610-917e4377364-d414-4ca5-a882-bcc9a15b9bd712025-08-11
71610-917-60EA - Each71610-917408a4184-50e6-446a-91e3-cd505d7576d912025-08-11
71610-917-70EA - Each71610-917414dfdc6-372d-48cc-b373-c46f53f7da7a12025-08-11
71610-917-80EA - Each71610-917d9a391b4-5ce8-47eb-90a8-f440be68379212025-08-11
71610-917-92EA - Each71610-917da072ba3-a22c-4b7a-87a7-ae8e21c0d9f612026-05-22
71610-917-94EA - Each71610-91743f449bc-8d73-4d56-9c04-7d77a56b9f4f12025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861007metFORMIN HCl 500 MG Oral TabletPSN388ee1e0-a0d2-324d-e063-6394a90a16642
861007metformin hydrochloride 500 MG Oral TabletSCD388ee1e0-a0d2-324d-e063-6394a90a16642

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-917-307161009173030 TABLET in 1 BOTTLE (71610-917-30) 30 tablet2025-06-26NoNoHistorical
71610-917-537161009175360 TABLET in 1 BOTTLE (71610-917-53) 60 tablet2025-06-26NoNoHistorical
71610-917-607161009176090 TABLET in 1 BOTTLE (71610-917-60) 90 tablet2025-06-26NoNoHistorical
71610-917-7071610091770120 TABLET in 1 BOTTLE (71610-917-70) 120 tablet2025-06-26NoNoHistorical
71610-917-8071610091780180 TABLET in 1 BOTTLE (71610-917-80) 180 tablet2025-06-26NoNoHistorical
71610-917-9271610091792270 TABLET in 1 BOTTLE (71610-917-92) 270 tablet2026-03-25NoNoHistorical
71610-917-9471610091794360 TABLET in 1 BOTTLE (71610-917-94) 360 tablet2025-06-26NoNoHistorical