FDA.reportPublic FDA data

METFORMIN HYDROCHLORIDE EXTENDED RELEASE

Product NDC
71610-454
11-digit product format
716100454
Labeler code
71610
Product ID
71610-454_1b06528a-d7ea-4ae9-b5c1-2cc175af1876
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METFORMIN HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090295
Marketing category
ANDA
Marketing start
2016-05-12
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
METFORMIN HYDROCHLORIDE EXTENDED RELEASE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii786Z46389E
Rxcui860975

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
71610-454-30METFORMIN HYDROCHLORIDE EXTENDED RELEASE30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE302
71610-454-53METFORMIN HYDROCHLORIDE EXTENDED RELEASE60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE602
71610-454-60METFORMIN HYDROCHLORIDE EXTENDED RELEASE90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE902
71610-454-70METFORMIN HYDROCHLORIDE EXTENDED RELEASE120 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1202
71610-454-80METFORMIN HYDROCHLORIDE EXTENDED RELEASE180 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1802
71610-454-92METFORMIN HYDROCHLORIDE EXTENDED RELEASE270 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE2702
71610-454-94METFORMIN HYDROCHLORIDE EXTENDED RELEASE360 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE3602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-454-30EA - Each71610-4541321919e-9754-4ee0-a14b-390d3600da7412020-09-14
71610-454-53EA - Each71610-454f0fc2bc5-69fa-4799-b540-1dc38781c2ae12020-09-14
71610-454-60EA - Each71610-4543f9edf3f-f570-452c-a64a-fea1ddbe2a0712020-09-14
71610-454-70EA - Each71610-4545c897e3d-4379-4033-a57c-e027b8c2c5a312020-09-14
71610-454-80EA - Each71610-45403f31944-9171-41bb-98e6-71699ca6b62012020-09-14
71610-454-92EA - Each71610-454756a9afd-cd5d-48ed-afd6-ffc5250b49e912020-09-14
71610-454-94EA - Each71610-454028a8fb2-7385-427f-b630-7fb8c99811f212022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-454METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 7 package rows20211209_0b843f12-a654-4751-be1f-55e6fce163c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN0b843f12-a654-4751-be1f-55e6fce163c92
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD0b843f12-a654-4751-be1f-55e6fce163c92
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY0b843f12-a654-4751-be1f-55e6fce163c92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-454-307161004543030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-454-30) 2020-08-100000-00-00NoNoCurrent
71610-454-537161004545360 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-454-53) 2020-08-100000-00-00NoNoCurrent
71610-454-607161004546090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-454-60) 2020-08-070000-00-00NoNoCurrent
71610-454-7071610045470120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-454-70) 2020-08-100000-00-00NoNoCurrent
71610-454-8071610045480180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-454-80) 2020-08-070000-00-00NoNoCurrent
71610-454-9271610045492270 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-454-92) 2020-08-070000-00-00NoNoCurrent
71610-454-9471610045494360 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-454-94) 2021-11-020000-00-00NoNoCurrent