FDA.reportPublic FDA data

Metformin

Product NDC
70010-491
11-digit product format
700100491
Labeler code
70010
Product ID
70010-491_451bc376-d523-ee84-e063-6394a90a4743
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin ER 500 mg
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
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
2026-12-31
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

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
70010-491-01Metformin100 in 1 BOTTLETABLET, EXTENDED RELEASE10019
70010-491-05Metformin500 in 1 BOTTLETABLET, EXTENDED RELEASE50019
70010-491-09Metformin90 in 1 BOTTLETABLET, EXTENDED RELEASE9019
70010-491-10Metformin1000 in 1 BOTTLETABLET, EXTENDED RELEASE100019
70010-491-18Metformin5000 in 1 POUCHTABLET, EXTENDED RELEASE500019
70010-491-19Metformin25000 in 1 CARTONTABLET, EXTENDED RELEASE2500019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-491-01EA - Each70010-491b67f0f6c-3e17-4980-902e-fb0a6751820912019-02-13
70010-491-05EA - Each70010-49110646451-2fb5-4fc1-8b3e-a2151b7ce20712019-02-13
70010-491-09EA - Each70010-491fb51e19d-32de-4ba0-954f-e3faf0ab8fca12020-08-06
70010-491-10EA - Each70010-49116eba94e-3cda-4acc-9d9f-3f24f2d75fcb12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-491METFORMIN (METFORMIN ER 500 MG) TABLET, EXTENDED RELEASE METFORMIN (METFORMIN ER 750 MG) TABLET, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.]18Current NDC, Legacy NDC, 6 package rows20240704_6d6ee6f8-9650-ff4f-e053-2991aa0acf19.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
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN1f823d36-c7a6-4cf8-b6f1-52b7a51c8fc4101
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD1f823d36-c7a6-4cf8-b6f1-52b7a51c8fc4101
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDc047cf64-467a-40f3-be46-a1926b3b8d56101
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY1f823d36-c7a6-4cf8-b6f1-52b7a51c8fc4101
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYc047cf64-467a-40f3-be46-a1926b3b8d56101
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNd9e0816d-fd61-1ac2-e053-2995a90a405419
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN6d6ee6f8-9650-ff4f-e053-2991aa0acf1919
860981metFORMIN HCl 750 MG 24HR Extended Release Oral TabletPSN6d6ee6f8-9650-ff4f-e053-2991aa0acf1919
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDd9e0816d-fd61-1ac2-e053-2995a90a405419
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD6d6ee6f8-9650-ff4f-e053-2991aa0acf1919
86098124 HR metformin hydrochloride 750 MG Extended Release Oral TabletSCD6d6ee6f8-9650-ff4f-e053-2991aa0acf1919
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYd9e0816d-fd61-1ac2-e053-2995a90a405419
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY6d6ee6f8-9650-ff4f-e053-2991aa0acf1919
860981metformin HCl 750 MG 24 HR Extended Release Oral TabletSY6d6ee6f8-9650-ff4f-e053-2991aa0acf1919
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNc6fddb05-6b9b-4088-8ce7-17fb94c13cc26
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDc6fddb05-6b9b-4088-8ce7-17fb94c13cc26
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYc6fddb05-6b9b-4088-8ce7-17fb94c13cc26
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNfdd3481c-aaec-47ac-9790-01de68b2e2534
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN92855c8d-59be-458b-97f1-2ff11b9bf6b04
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN5c10eaa2-d6ba-446a-8f16-f5a8ca7223d74
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN05999192-ebc6-4198-bd1e-f46abbfb4f8a4
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD92855c8d-59be-458b-97f1-2ff11b9bf6b04
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD5c10eaa2-d6ba-446a-8f16-f5a8ca7223d74
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCD05999192-ebc6-4198-bd1e-f46abbfb4f8a4
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDfdd3481c-aaec-47ac-9790-01de68b2e2534
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY05999192-ebc6-4198-bd1e-f46abbfb4f8a4
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY92855c8d-59be-458b-97f1-2ff11b9bf6b04
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYfdd3481c-aaec-47ac-9790-01de68b2e2534
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSY5c10eaa2-d6ba-446a-8f16-f5a8ca7223d74
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNf29892f8-142e-4d24-9ccd-5d6b408328cd3
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDf29892f8-142e-4d24-9ccd-5d6b408328cd3
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYf29892f8-142e-4d24-9ccd-5d6b408328cd3
860975metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSNe2c52c13-2206-6c71-e053-2a95a90aef0a1
86097524 HR metformin hydrochloride 500 MG Extended Release Oral TabletSCDe2c52c13-2206-6c71-e053-2a95a90aef0a1
860975metformin HCl 500 MG 24 HR Extended Release Oral TabletSYe2c52c13-2206-6c71-e053-2a95a90aef0a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70010-491-0170010049101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-01) 2018-07-310000-00-00NoNoCurrent
70010-491-0570010049105500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-05) 2018-07-310000-00-00NoNoCurrent
70010-491-097001004910990 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-09) 2020-04-160000-00-00NoNoCurrent
70010-491-10700100491101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-10) 2018-07-310000-00-00NoNoCurrent
70010-491-18700100491185000 TABLET, EXTENDED RELEASE in 1 POUCH (70010-491-18) 2019-06-140000-00-00NoNoCurrent
70010-491-197001004911925000 TABLET, EXTENDED RELEASE in 1 CARTON (70010-491-19) 2019-06-140000-00-00NoNoCurrent