NDC codes

FDA NDC Directory
Product NDC (as listed)36000-242Labeler and product segments. Claims need a package NDC.
Product NDC at billing width36000-0242Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
36000-242-0136000024201360000242011 VIAL, MULTI-DOSE in 1 CARTON (36000-242-01) / 30 mL in 1 VIAL, MULTI-DOSEMarketed from Jul 15, 2016

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Tobramycin
Generic name (nonproprietary)
tobramycin
Active ingredients
Tobramycin sulfate — 40 mg/mL
Dosage form
Injection
Route
Intramuscular, Intravenous
Labeler
Baxter Healthcare CorporationNDC labeler code 36000
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206965
Marketing start
Listing expires
Other FDA classes
Aminoglycosides (Chemical structure)
Identifiers
Product ID 36000-242_19ade85b-3da4-44af-8ad0-d68d15a48193SPL ID 19ade85b-3da4-44af-8ad0-d68d15a48193SPL set ID a9897444-71f6-42af-9b71-4aa77829ade0RxCUI 597823UNII HJT0RXD7JKUPC 0336000244015, 0336000242011
Pharmacologic class
Aminoglycoside Antibacterial

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N436000024201 followed by a unit qualifier and the quantity

Package 36000-0242-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: Septicemia in the neonate, child, and adult caused by P. aeruginosa , E. coli , and Klebsiella sp. Lower respiratory tract infections caused by P. aeruginosa , Klebsiella sp, Enterobacter sp, Serratia sp, E. coli , and S. aureus (penicillinase and non-penicillinase-producing strains). Serious central-nervous-system infections (meningitis) caused by susceptible organisms. Intra-abdominal infections, including peritonitis, caused by E. coli , Klebsiella sp, and Enterobacter sp. Skin, bone, and skin-structure…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 36000-242

What is NDC 36000-242?
36000-242 is the product NDC for Tobramycin, Tobramycin sulfate 40 mg/mL injection, listed with the FDA by Baxter Healthcare Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tobramycin.
What is the active ingredient?
Tobramycin sulfate.
Who is the labeler?
Baxter Healthcare Corporation, NDC labeler code 36000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tobramycin?
55 other product NDCs are listed under this name. See all Tobramycin NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tobramycin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TobramycinTobramycin 3 mg/mLSolutionOphthalmicPreferred Pharmaceuticals Inc.68788-414968788-4149-05
TobramycinTobramycin 3 mg/mLSolution/ dropsOphthalmicJVET PHARMACEUTICALS LLC86211-11086211-0110-01
TobramycinTobramycin 300 mg/5mLSolutionRespiratory (Inhalation)Ritedose Pharmaceuticals, LLC76204-02976204-0029-56
TobramycinTobramycin 300 mg/4mLSolutionRespiratory (Inhalation)NorthStar RxLLC72603-63072603-0630-56
TobramycinTobramycin 300 mg/5mLSolutionRespiratory (Inhalation)NorthStar RxLLC72603-43072603-0430-56
TobramycinTobramycin 300 mg/5mLSolutionRespiratory (Inhalation)American Health Packaging60687-73160687-0731-83
TobramycinTobramycin sulfate 1.2 g/30mLInjection, Powder, Lyophilized, For solutionIntravenousNorthstar Rx LLC72603-16072603-0160-06
TobramycinTobramycin 3 mg/mLSolution/ dropsOphthalmicBelcher Pharmaceuticals, LLC62250-11062250-0110-01
Tobramycintobramycin solutionTobramycin 300 mg/5mLInhalantRespiratory (Inhalation)Micro Labs Limited42571-40842571-0408-92
TobramycinTobramycin 300 mg/5mLSolutionRespiratory (Inhalation)Lifestar Pharma LLC70756-60470756-0604-56

All 56 Tobramycin NDCs

Other NDCs under ANDA 206965

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 206965
ProductStrengthForm · routeLabelerProduct NDC
TobramycinTobramycin sulfate 40 mg/mLInjectionIntramuscular, IntravenousBaxter Healthcare Corporation36000-244

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