FDA.reportPublic FDA data

TOBRAMYCIN

Product NDC
70756-604
11-digit product format
707560604
Labeler code
70756
Product ID
70756-604_0d769be2-4528-456f-af6b-2e1d1ad90c13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Lifestar Pharma LLC
Application
ANDA214478
Marketing category
ANDA
Marketing start
2023-06-30
Substance
TOBRAMYCIN
Active strength
300 mg/5mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TOBRAMYCIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOBRAMYCIN300 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZ8RRZ51VK
Rxcui348719

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
70756-604-44TOBRAMYCIN5 mL in 1 AMPULESOLUTION56
70756-604-44TOBRAMYCIN4 in 1 POUCHSOLUTION46
70756-604-56TOBRAMYCIN14 in 1 CARTONSOLUTION146

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-604-56ML - Milliliter70756-604ebf91c12-bbb0-471a-8513-352a9106fcbb12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-604TOBRAMYCIN SOLUTION [LIFESTAR PHARMA LLC]6Current NDC, 3 package rows20240823_5563e8af-c6c9-42a2-974d-7d364a47f00a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
348719tobramycin 300 MG in 5 ML Inhalation SolutionPSN5563e8af-c6c9-42a2-974d-7d364a47f00a6
348719tobramycin 60 MG/ML Inhalation SolutionSCD5563e8af-c6c9-42a2-974d-7d364a47f00a6
348719tobramycin 300 MG per 5 ML Inhalation SolutionSY5563e8af-c6c9-42a2-974d-7d364a47f00a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70756-604-44707560604445 mL in 1 AMPULE5 mlHistorical
70756-604-567075606045614 POUCH in 1 CARTON (70756-604-56) / 4 AMPULE in 1 POUCH (70756-604-44) / 5 mL in 1 AMPULE14 pouch2023-06-30NoNoCurrent