FDA.reportPublic FDA data

METFORMIN HYDROCHLORIDE

Product NDC
23155-843
11-digit product format
231550843
Labeler code
23155
Product ID
23155-843_5de825b4-d3e9-474d-9f17-ceed2d4ea87c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metformin hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA213320
Marketing category
ANDA
Marketing start
2023-01-19
Marketing end
2027-04-30
Substance
METFORMIN HYDROCHLORIDE
Active strength
1000 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
METFORMIN HYDROCHLORIDE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE1000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii786Z46389E
Rxcui861004, 861007, 861010

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
23155-843-01METFORMIN HYDROCHLORIDE100 in 1 BOTTLETABLET1004
23155-843-05METFORMIN HYDROCHLORIDE500 in 1 BOTTLETABLET5004
23155-843-10METFORMIN HYDROCHLORIDE1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-843-01EA - Each23155-84360256a51-c717-4341-9d8e-656c244cc81712023-04-07
23155-843-05EA - Each23155-843fa23fafb-fa46-4ea2-b8bc-fef4e0ccc7a212023-04-07
23155-843-10EA - Each23155-8437960bdfd-46aa-4a62-95ec-e1d112716b0d12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-843METFORMIN HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]3Current NDC, 3 package rows20230419_b63bfafa-db4c-4fb8-84cd-ff73a5e7d320.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861004metFORMIN HCl 1000 MG Oral TabletPSNb63bfafa-db4c-4fb8-84cd-ff73a5e7d3204
861007metFORMIN HCl 500 MG Oral TabletPSNb63bfafa-db4c-4fb8-84cd-ff73a5e7d3204
861010metFORMIN HCl 850 MG Oral TabletPSNb63bfafa-db4c-4fb8-84cd-ff73a5e7d3204
861004metformin hydrochloride 1000 MG Oral TabletSCDb63bfafa-db4c-4fb8-84cd-ff73a5e7d3204
861007metformin hydrochloride 500 MG Oral TabletSCDb63bfafa-db4c-4fb8-84cd-ff73a5e7d3204
861010metformin hydrochloride 850 MG Oral TabletSCDb63bfafa-db4c-4fb8-84cd-ff73a5e7d3204
861004metformin HCl 1 GM Oral TabletSYb63bfafa-db4c-4fb8-84cd-ff73a5e7d3204
861004metFORMIN HCl 1000 MG Oral TabletPSN066f01e1-6c46-2d4f-e063-6294a90a2dab2
861004metFORMIN HCl 1000 MG Oral TabletPSN4182bcf0-1f9a-4f3a-9428-86b5d757954f2
861004metFORMIN HCl 1000 MG Oral TabletPSN0865f83f-0f34-0690-e063-6294a90abf042
861004metformin hydrochloride 1000 MG Oral TabletSCD4182bcf0-1f9a-4f3a-9428-86b5d757954f2
861004metformin hydrochloride 1000 MG Oral TabletSCD0865f83f-0f34-0690-e063-6294a90abf042
861004metformin hydrochloride 1000 MG Oral TabletSCD066f01e1-6c46-2d4f-e063-6294a90a2dab2
861004metformin HCl 1 GM Oral TabletSY4182bcf0-1f9a-4f3a-9428-86b5d757954f2
861004metformin HCl 1 GM Oral TabletSY0865f83f-0f34-0690-e063-6294a90abf042
861004metformin HCl 1 GM Oral TabletSY066f01e1-6c46-2d4f-e063-6294a90a2dab2
861004metFORMIN HCl 1000 MG Oral TabletPSN3ac4e864-4b8a-13b1-e063-6294a90ada661
861004metFORMIN HCl 1000 MG Oral TabletPSN3cbb802d-d493-255e-e063-6294a90a32f21
861004metFORMIN HCl 1000 MG Oral TabletPSN2d7d9364-e71d-4ef6-e063-6394a90af8411
861004metformin hydrochloride 1000 MG Oral TabletSCD3ac4e864-4b8a-13b1-e063-6294a90ada661
861004metformin hydrochloride 1000 MG Oral TabletSCD3cbb802d-d493-255e-e063-6294a90a32f21
861004metformin hydrochloride 1000 MG Oral TabletSCD2d7d9364-e71d-4ef6-e063-6394a90af8411
861004metformin HCl 1 GM Oral TabletSY3ac4e864-4b8a-13b1-e063-6294a90ada661
861004metformin HCl 1 GM Oral TabletSY3cbb802d-d493-255e-e063-6294a90a32f21
861004metformin HCl 1 GM Oral TabletSY2d7d9364-e71d-4ef6-e063-6394a90af8411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-843-0123155084301100 TABLET in 1 BOTTLE (23155-843-01) 100 tablet2023-01-192026-12-31NoNoHistorical
23155-843-0523155084305500 TABLET in 1 BOTTLE (23155-843-05) 500 tablet2023-01-192027-01-31NoNoHistorical
23155-843-10231550843101000 TABLET in 1 BOTTLE (23155-843-10) 1000 tablet2023-08-302027-04-30NoNoHistorical