Amikacin Sulfate

Product NDC
0703-9032
11-digit product format
007039032
Labeler code
0703
Product ID
0703-9032_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
500 mg/2mL
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
0703-9032-01ML - Milliliter0703-90320b81b9a8-a525-4313-8ad0-9a1a76a5497312012-07-24
0703-9032-03ML - Milliliter0703-9032c849d133-93a4-4032-9bc0-e18a0b67848812012-07-24
0703-9032-91ML - Milliliter0703-903270a6a89f-2c2c-40de-955b-cefdefece38f12016-11-08
0703-9032-93ML - Milliliter0703-9032abd3f17a-a95d-435f-9e87-dc1b31b6b1d812014-12-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0703-9032-030070390320310 VIAL, SINGLE-DOSE in 1 CARTON (0703-9032-03) > 2 mL in 1 VIAL, SINGLE-DOSE (0703-9032-01) 1993-10-010000-00-00NoNoCurrent