Metformin

Product NDC
72162-2424
11-digit product format
721622424
Labeler code
72162
Product ID
72162-2424_8d9a5ffd-46d2-4aa5-ab60-1eb88842f880
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin ER 500 mg
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209313
Marketing category
ANDA
Marketing start
2018-07-31
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
Listing expiration
2027-12-31

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
72162-2424-0Metformin1000 in 1 BOTTLETABLET, EXTENDED RELEASE1000101
72162-2424-1Metformin100 in 1 BOTTLETABLET, EXTENDED RELEASE100101
72162-2424-2Metformin50 in 1 BOTTLETABLET, EXTENDED RELEASE50101
72162-2424-4Metformin180 in 1 BOTTLETABLET, EXTENDED RELEASE180101
72162-2424-5Metformin500 in 1 BOTTLETABLET, EXTENDED RELEASE500101
72162-2424-7Metformin360 in 1 BOTTLETABLET, EXTENDED RELEASE360101
72162-2424-9Metformin90 in 1 BOTTLETABLET, EXTENDED RELEASE90101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2424-0EA - Each72162-242491694f90-e166-48bf-80d0-593eab2ceb6d12024-12-10
72162-2424-1EA - Each72162-24242bdfc414-6ffb-436e-9d46-a426b4fa27f612024-12-10
72162-2424-2EA - Each72162-242438d3f3d2-30bb-481c-802a-7f04f1ae949412024-12-10
72162-2424-4EA - Each72162-242403c13ee4-9c27-4063-b7f0-9c4b648c6e2712024-12-10
72162-2424-5EA - Each72162-242413b33fbd-50d4-4f73-81c2-4527532e9b8212024-12-10
72162-2424-7EA - Each72162-242489627c8e-cbeb-45f6-bc2b-6b33eb1c6f9112024-12-10
72162-2424-9EA - Each72162-2424646cbc71-a8bc-4e1a-b569-5e4dfe39af0b12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2424METFORMIN (METFORMIN ER 500 MG) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]100Current NDC, 7 package rows20241114_c047cf64-467a-40f3-be46-a1926b3b8d56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNc047cf64-467a-40f3-be46-a1926b3b8d56101
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDc047cf64-467a-40f3-be46-a1926b3b8d56101
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYc047cf64-467a-40f3-be46-a1926b3b8d56101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2424-0721622424001000 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2424-0) 2018-07-31NoNoHistorical
72162-2424-172162242401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2424-1) 2018-07-31NoNoHistorical
72162-2424-27216224240250 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2424-2) 2018-07-31NoNoHistorical
72162-2424-472162242404180 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2424-4) 2018-07-31NoNoHistorical
72162-2424-572162242405500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2424-5) 2018-07-31NoNoHistorical
72162-2424-772162242407360 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2424-7) 2018-07-31NoNoHistorical
72162-2424-97216224240990 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2424-9) 2018-07-31NoNoHistorical