FDA.reportPublic FDA data

Tobramycin

Product NDC
67877-678
11-digit product format
678770678
Labeler code
67877
Product ID
67877-678_25c12569-0ae1-4117-a945-edfc5457e525
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Ascend Laboratories, LLC
Application
ANDA212848
Marketing category
ANDA
Marketing start
2021-04-02
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
67877-678-69Tobramycin5 mL in 1 AMPULESOLUTION58
67877-678-69Tobramycin7 in 1 POUCHSOLUTION78
67877-678-70Tobramycin56 in 1 CARTONSOLUTION568

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-678-69ML - Milliliter67877-6781be92630-1817-4488-b54e-c8a855ea5adb12022-03-09
67877-678-70ML - Milliliter67877-678f1e475f6-7d7f-4674-9170-a100ce67ef4512022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-678TOBRAMYCIN SOLUTION [ASCEND LABORATORIES, LLC]8Current NDC, Legacy NDC, 3 package rows20240111_845e3328-fffa-44eb-b78a-3607c05fdd55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
348719tobramycin 300 MG in 5 ML Inhalation SolutionPSN845e3328-fffa-44eb-b78a-3607c05fdd558
348719tobramycin 60 MG/ML Inhalation SolutionSCD845e3328-fffa-44eb-b78a-3607c05fdd558
348719tobramycin 300 MG per 5 ML Inhalation SolutionSY845e3328-fffa-44eb-b78a-3607c05fdd558

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-678-69678770678695 mL in 1 AMPULE5 mlHistorical
67877-678-706787706787056 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE56 pouch2021-04-020000-00-00NoNoCurrent