FDA.reportPublic FDA data

Metformin Hydrochloride

Product NDC
51655-549
11-digit product format
516550549
Labeler code
51655
Product ID
51655-549_40b46ae3-defa-4ad5-b27d-88c7837c9c96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
ANDA075967
Marketing category
ANDA
Marketing start
2015-01-09
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-549-832026-01-05C16284748780-19d75b9d0-b248-f424-e053-dadaa90a57ced2583e6b-c06d-4618-914c-18d9917706a6
51655-549-832020-01-31C16284748780-19d75b9d0-b248-f424-e053-dadaa90a57ced2583e6b-c06d-4618-914c-18d9917706a6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EMETFORMIN HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]1
METFORMINACTIVE MOIETY9100L32L2NMETFORMIN HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-549METFORMIN HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]1Legacy NDC20150122_d2583e6b-c06d-4618-914c-18d9917706a6.zip