Minocycline Hydrochloride

Product NDC
0781-5387
11-digit product format
007815387
Labeler code
0781
Product ID
0781-5387_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
135 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
0781-5387-01EA - Each0781-53875a3d58c4-4df5-45c1-b5d5-2f012bd6d63612012-07-24
0781-5387-31EA - Each0781-5387227f85f0-70d8-401d-8628-2c3ec0fd09ac12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-5387-0100781538701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5387-01) 2009-08-130000-00-00NoNoCurrent
0781-5387-10007815387101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5387-10) 2009-08-130000-00-00NoNoCurrent
0781-5387-310078153873130 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5387-31) 2009-08-130000-00-00NoNoCurrent