METFORMIN HYDROCHLORIDE EXTENDED RELEASE

Product NDC
68788-8225
11-digit product format
687888225
Labeler code
68788
Product ID
68788-8225_2afcf9f5-2cc7-423c-947e-396da86119ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METFORMIN HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred PHarmaceuticals Inc.
Application
ANDA090295
Marketing category
ANDA
Marketing start
2022-09-12
Marketing end
0000-00-00
Substance
METFORMIN HYDROCHLORIDE
Active strength
750 mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8225-1EA - Each68788-8225b62e008f-7545-44b5-9c23-048a5802c48e12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8225METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]3Legacy NDC20240707_2afcf9f5-2cc7-423c-947e-396da86119ad.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8225-168788822501100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68788-8225-1) 2022-09-120000-00-00NoNoCurrent