Minocycline Hydrochloride

Product NDC
42546-771
11-digit product format
425460771
Labeler code
42546
Product ID
42546-771_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
45 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
42546-771-30EA - Each42546-77105a8f88a-8dbd-4571-9d84-05db2be42a6d12015-11-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42546-771-304254607713030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42546-771-30) 2012-11-190000-00-00NoNoCurrent