Tobramycin

Product NDC
39822-0409
11-digit product format
398220409
Labeler code
39822
Product ID
39822-0409_284f9119-9230-443d-be91-2ed6a7dbe355
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
X-GEN Pharmaceuticals, Inc.
Application
ANDA065013
Marketing category
ANDA
Marketing start
2001-08-17
Marketing end
0000-00-00
Substance
TOBRAMYCIN SULFATE
Active strength
1 g/30mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
39822-0409-62020-02-25C16284748780-19d75b9d0-c5c5-f424-e053-dadaa90a57ce3cb82c1f-b0b9-4e90-ae3d-15f866a4e0e5
39822-0409-62020-01-31C16284748780-19d75b9d0-c5c5-f424-e053-dadaa90a57ce3cb82c1f-b0b9-4e90-ae3d-15f866a4e0e5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-0409-1EA - Each39822-0409392d90e1-1d75-4673-902f-3bafa09f301612014-08-01
39822-0409-6EA - Each39822-04096b2df3ff-f073-4dc2-a453-f96192a07b8c12014-08-01