TIGECYCLINE

Product NDC
16729-364
11-digit product format
167290364
Labeler code
16729
Product ID
16729-364_cc192d08-55de-6825-e053-2a95a90a1ce2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TIGECYCLINE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Accord Healthcare Inc.
Application
NDA208744
Marketing category
NDA
Marketing start
2019-03-28
Marketing end
0000-00-00
Substance
TIGECYCLINE
Active strength
50 mg/10mL
Pharmacologic classes
Tetracycline-class Antibacterial [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-364-03EA - Each16729-36414a7d6e5-dab4-4b38-84a1-c0bf3de1898c12019-04-11
16729-364-68EA - Each16729-364824ad7bc-b0f0-402d-b951-b71e45934bd812019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-364-681672903646810 VIAL, SINGLE-DOSE in 1 CARTON (16729-364-68) > 10 mL in 1 VIAL, SINGLE-DOSE (16729-364-03) 2019-03-280000-00-00NoNoCurrent