Minocycline Hydrochloride

Product NDC
42546-777
11-digit product format
425460777
Labeler code
42546
Product ID
42546-777_68acdc1d-a4e9-48a8-b5d5-71a6681ae7ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
PruGen Pharmaceuticals
Application
ANDA202261
Marketing category
ANDA
Marketing start
2012-11-19
Marketing end
0000-00-00
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
135 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [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
42546-777-30EA - Each42546-777f9ba9ef3-ca09-4205-9f84-7f578c074f2612015-11-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42546-777-304254607773030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42546-777-30) 2012-11-190000-00-00NoNoCurrent