FDA.reportPublic FDA data

Metformin hydrochloride

Product NDC
42291-825
11-digit product format
422910825
Labeler code
42291
Product ID
42291-825_42c9e096-bccc-ad6e-e063-6294a90a4e5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA207427
Marketing category
ANDA
Marketing start
2024-06-11
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii786Z46389E
Rxcui860975, 860981

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
42291-825-10Metformin hydrochloride1000 in 1 BOTTLETABLET, EXTENDED RELEASE10003
42291-825-12Metformin hydrochloride120 in 1 BOTTLETABLET, EXTENDED RELEASE1203
42291-825-18Metformin hydrochloride180 in 1 BOTTLETABLET, EXTENDED RELEASE1803
42291-825-30Metformin hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE303
42291-825-36Metformin hydrochloride360 in 1 BOTTLETABLET, EXTENDED RELEASE3603
42291-825-60Metformin hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE603
42291-825-90Metformin hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-825-10EA - Each42291-8250864c9eb-69f8-463b-8448-6258d43e374a12024-07-12
42291-825-12EA - Each42291-825a6dba25c-ecc6-4caf-9dda-e6ce744f4bc012024-07-12
42291-825-18EA - Each42291-825cd5310cf-0eba-4a37-8055-0a608efb3f1912024-07-12
42291-825-30EA - Each42291-825e0234a65-9122-45fb-8c17-a4e2c195fd1b12025-12-16
42291-825-36EA - Each42291-82592f2c384-a9e8-4527-a072-a2e786f19f1212024-07-12
42291-825-60EA - Each42291-825ed35a3b7-c5fd-4e11-b32a-29e9936bdcce12025-12-16
42291-825-90EA - Each42291-825d2054660-3f28-4bfe-b738-108b90afe21312024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-825METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE METFORMIN HYDROCHLORIDE ER (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AVKARE]1Current NDC, 7 package rows20240613_1aa40000-877f-8ea4-e063-6394a90a0e31.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN1aa40000-877f-8ea4-e063-6394a90a0e313
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSN1aa40000-877f-8ea4-e063-6394a90a0e313
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD1aa40000-877f-8ea4-e063-6394a90a0e313
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCD1aa40000-877f-8ea4-e063-6394a90a0e313
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY1aa40000-877f-8ea4-e063-6394a90a0e313
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSY1aa40000-877f-8ea4-e063-6394a90a0e313
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN242538d7-fb79-4df6-e063-6394a90a5b961
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD242538d7-fb79-4df6-e063-6394a90a5b961
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY242538d7-fb79-4df6-e063-6394a90a5b961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42291-825-10422910825101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-10) 2024-06-11NoNoCurrent
42291-825-1242291082512120 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-12) 2024-06-11NoNoCurrent
42291-825-1842291082518180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-18) 2024-06-11NoNoCurrent
42291-825-304229108253030 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-30) 2025-11-03NoNoCurrent
42291-825-3642291082536360 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-36) 2024-06-11NoNoCurrent
42291-825-604229108256060 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-60) 2025-11-03NoNoCurrent
42291-825-904229108259090 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-825-90) 2024-06-11NoNoCurrent