Amikacin Sulfate

Product NDC
0703-9040
11-digit product format
007039040
Labeler code
0703
Product ID
0703-9040_e048528f-1bf9-4735-85a3-2302ffa01696
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amikacin Sulfate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Teva Parenteral Medicines, Inc.
Application
ANDA064045
Marketing category
ANDA
Marketing start
1993-10-01
Marketing end
0000-00-00
Substance
AMIKACIN SULFATE
Active strength
1 g/4mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [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
0703-9040-01ML - Milliliter0703-9040e9d7c748-76ad-4fbc-a7a7-e556918a60c812012-07-24
0703-9040-03ML - Milliliter0703-9040a1a27f10-f0fb-4e01-b0f1-93afbcb468b912012-07-24
0703-9040-91ML - Milliliter0703-9040d58290ae-a8f2-450f-9332-43b8f68564ab12016-11-08
0703-9040-93ML - Milliliter0703-904034bb5ba8-4636-406f-82fb-1a09a8fa692012014-12-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0703-9040-030070390400310 VIAL, SINGLE-DOSE in 1 CARTON (0703-9040-03) > 4 mL in 1 VIAL, SINGLE-DOSE (0703-9040-01) 1993-10-010000-00-00NoNoCurrent