FDA.reportPublic FDA data

Metformin HCl ER

Product NDC
51655-551
11-digit product format
516550551
Labeler code
51655
Product ID
51655-551_2f2c9853-4107-4d93-9d00-cc2175ee75eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride Extended Release
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
ANDA077336
Marketing category
ANDA
Marketing start
2015-05-22
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Biguanide [EPC],Biguanides [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-551-822026-01-10C16284748780-19d75b9d0-19f3-f424-e053-dadaa90a57ceMetformin HCL ER 500mg
51655-551-822020-01-31C16284748780-19d75b9d0-19f3-f424-e053-dadaa90a57ceMetformin HCL ER 500mg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HCL ER (METFORMIN HYDROCHLORIDE EXTENDED RELEASE) TABLET [NORTHWIND PHARMACEUTICALS]1
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HCL ER (METFORMIN HYDROCHLORIDE EXTENDED RELEASE) TABLET [NORTHWIND PHARMACEUTICALS]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETFORMIN HCL ER (METFORMIN HYDROCHLORIDE EXTENDED RELEASE) TABLET [NORTHWIND PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METFORMIN HCL ER (METFORMIN HYDROCHLORIDE EXTENDED RELEASE) TABLET [NORTHWIND PHARMACEUTICALS]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETFORMIN HCL ER (METFORMIN HYDROCHLORIDE EXTENDED RELEASE) TABLET [NORTHWIND PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METFORMIN HCL ER (METFORMIN HYDROCHLORIDE EXTENDED RELEASE) TABLET [NORTHWIND PHARMACEUTICALS]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TMETFORMIN HCL ER (METFORMIN HYDROCHLORIDE EXTENDED RELEASE) TABLET [NORTHWIND PHARMACEUTICALS]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMETFORMIN HCL ER (METFORMIN HYDROCHLORIDE EXTENDED RELEASE) TABLET [NORTHWIND PHARMACEUTICALS]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEMETFORMIN HCL ER (METFORMIN HYDROCHLORIDE EXTENDED RELEASE) TABLET [NORTHWIND PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-551METFORMIN HCL ER (METFORMIN HYDROCHLORIDE EXTENDED RELEASE) TABLET [NORTHWIND PHARMACEUTICALS]1Legacy NDC20150522_184f584a-e684-4866-a6d6-57f003726796.zip