METFORMIN HYDROCHLORIDE EXTENDED RELEASE

Product NDC
61919-450
11-digit product format
619190450
Labeler code
61919
Product ID
61919-450_92d9199c-7ebe-8db7-e053-2995a90a87c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METFORMIN HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA201991
Marketing category
ANDA
Marketing start
2017-02-10
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
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-450-902023-01-30C16284748780-1f386c64a-2771-0266-e053-dadaa90a7c1aMETFORMIN HCL ER

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-450-30EA - Each61919-450c6fb9259-1758-452b-afa5-90957eae86d012026-02-05
61919-450-60EA - Each61919-450dcbf6945-ba5d-4fda-b64d-58ff8406135012016-02-04
61919-450-90EA - Each61919-4507c6619cf-7555-49d2-9933-44e8819e474212019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-450METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DIRECT_RX]2Legacy NDC20190919_4833deea-a19d-63b1-e054-00144ff8d46c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-450-906191904509090 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-450-90) 2019-09-180000-00-00NoNoCurrent