FDA.reportPublic FDA data

Tobramycin

Product NDC
39822-0412
11-digit product format
398220412
Labeler code
39822
Product ID
39822-0412_40a90656-9bc2-494b-e063-6294a90a04f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
XGen Pharmaceuticals DJB, Inc.
Application
ANDA065013
Marketing category
ANDA
Marketing start
2001-08-17
Substance
TOBRAMYCIN SULFATE
Active strength
1.2 g/30mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tobramycin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOBRAMYCIN SULFATE1.2 g/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHJT0RXD7JK
Rxcui597823

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f297c7c1-845a-4369-8c02-c51b92d6ae8eProduct name320240725
551d952d-4ce2-24f0-9ab0-630ad9aae596Product name220231211
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
9cfa145f-dbe9-bc02-83c2-692786ef6676Product name920210928
2f9713b8-5e7e-bbcc-b364-1b2c27a63796Product name420210903
32a533bc-01c7-2b9f-bbf7-ecfb0d964277Product name420210625
9f5124fb-08b0-4c3e-8e12-a1a6ff310cbaProduct name120150309
745a62af-e1c0-4ca3-6d6e-2b6455b903beProduct name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508
ef5b7aed-2b01-3ba8-5a1c-3bc9c9f03bb1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39822-0412-1Tobramycin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,127
39822-0412-1Tobramycin30 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,3027
39822-0412-6Tobramycin6 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,627
39822-0412-6Tobramycin30 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,3027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-0412-1EA - Each39822-04123f999960-0cf0-4181-b285-b2112146976a12012-07-24
39822-0412-6EA - Each39822-041276dcde81-f11f-4a94-b41b-7aa8c6a72a2912013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOBRAMYCIN SULFATEACTIVE INGREDIENTHJT0RXD7JKTOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.]16
TOBRAMYCINACTIVE MOIETYVZ8RRZ51VKTOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.]16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39822-0412TOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XGEN PHARMACEUTICALS DJB, INC.]26Current NDC, Legacy NDC, 4 package rows20230328_a384641c-04e3-4ab5-b152-7408cd07b64d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597823tobramycin 40 MG/ML Injectable SolutionPSNa384641c-04e3-4ab5-b152-7408cd07b64d27
597823tobramycin 40 MG/ML Injectable SolutionSCDa384641c-04e3-4ab5-b152-7408cd07b64d27
597823tobramycin (as tobramycin sulfate) 40 MG/ML Injectable SolutionSYa384641c-04e3-4ab5-b152-7408cd07b64d27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39822-0412-1398220412011 VIAL in 1 CARTON (39822-0412-1) / 30 mL in 1 VIAL1 vial2001-08-170000-00-00NoNoCurrent
39822-0412-6398220412066 VIAL in 1 CARTON (39822-0412-6) / 30 mL in 1 VIAL6 vial2001-08-170000-00-00NoNoCurrent