FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
42291-497
11-digit product format
422910497
Labeler code
42291
Product ID
42291-497_51b58596-4ac2-f23a-e063-6294a90a0a8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA078596
Marketing category
ANDA
Marketing start
2022-03-28
Marketing end
2026-05-31
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Current FDA listing
Yes

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
42291-497-01Metformin Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE1004
42291-497-05Metformin Hydrochloride50 in 1 BOTTLETABLET, EXTENDED RELEASE504
42291-497-10Metformin Hydrochloride1000 in 1 BOTTLETABLET, EXTENDED RELEASE10004
42291-497-12Metformin Hydrochloride120 in 1 BOTTLETABLET, EXTENDED RELEASE1204
42291-497-18Metformin Hydrochloride180 in 1 BOTTLETABLET, EXTENDED RELEASE1804
42291-497-36Metformin Hydrochloride360 in 1 BOTTLETABLET, EXTENDED RELEASE3604
42291-497-50Metformin Hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE5004
42291-497-90Metformin Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-497METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AVKARE]2Current NDC, Legacy NDC, 1 package rows20231117_db4a1415-6d46-15bb-e053-2a95a90a3c97.zip
42291-497METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AVKARE]2Current NDC, Legacy NDC, 7 package rows20230426_db893bbe-95af-bbec-e053-2a95a90ae0e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN6b8824c0-ece0-4b15-ba71-e893d6d2bfdf1
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD6b8824c0-ece0-4b15-ba71-e893d6d2bfdf1
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY6b8824c0-ece0-4b15-ba71-e893d6d2bfdf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-497-0142291049701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-01) 2022-03-312026-05-31NoNoCurrent
42291-497-054229104970550 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-05) 2023-04-252026-05-31NoNoHistorical
42291-497-10422910497101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-10) 2022-03-282026-05-31NoNoCurrent
42291-497-1242291049712120 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-12) 2023-04-252026-05-31NoNoHistorical
42291-497-1842291049718180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-18) 2022-03-310000-00-00NoNoCurrent
42291-497-3642291049736360 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-36) 2022-03-310000-00-00NoNoCurrent
42291-497-5042291049750500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-50) 2023-04-252026-05-31NoNoHistorical
42291-497-904229104979090 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-497-90) 2022-03-310000-00-00NoNoCurrent