Minocycline Hydrochloride

Product NDC
0781-5385
11-digit product format
007815385
Labeler code
0781
Product ID
0781-5385_b2dfcb1c-526b-4678-8a71-e6fc12b6db5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA090422
Marketing category
ANDA
Marketing start
2009-08-13
Marketing end
0000-00-00
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
45 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5385-01EA - Each0781-53851b71d24d-a3db-4f61-8238-4e10f4196ec712012-07-24
0781-5385-31EA - Each0781-5385fbde5d4a-925b-4b05-bda2-990b8647ecdb12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-5385-0100781538501100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5385-01) 2009-08-130000-00-00NoNoCurrent
0781-5385-10007815385101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5385-10) 2009-08-130000-00-00NoNoCurrent
0781-5385-310078153853130 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5385-31) 2009-08-130000-00-00NoNoCurrent