What is NDC 0093-4085?

0093-4085 is the product NDC for Tobramycin, Tobramycin 300 mg/5mL solution, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tobramycin NDC 0093-4085 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0093-4085Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00093-4085Add 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 NDC	11-digit (billing)	Package	Copy
0093-4085-63	0009340856300093408563	56 AMPULE in 1 CARTON (0093-4085-63) / 5 mL in 1 AMPULEMarketed from Nov 19, 2013

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 300 mg/5mL
Dosage form: Solution
Route: Respiratory (Inhalation)
Labeler: Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091589
Marketing start: Nov 19, 2013
Listing expires: Dec 31, 2027
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 0093-4085_2aeb6242-a55e-4e45-96df-f2d26616e167SPL ID 2aeb6242-a55e-4e45-96df-f2d26616e167SPL set ID c5f65e5b-c851-45da-a0e8-215d9a4e6ad3RxCUI 348719UNII VZ8RRZ51VK
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.

NDC on a medical claim

N400093408563 followed by a unit qualifier and the quantity

Package 00093-4085-63. 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 Oct 31, 2023.

Indications (excerpt from the label)

Tobramycin inhalation solution is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa . Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV 1 ) <25% or >75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies ( 14 )]. Tobramycin inhalation solution is an aminoglycoside antibacterial indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa . ( 1 ) Safety and efficacy have not been demonstrated in patients under the age o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0093-4085

What is NDC 0093-4085?: 0093-4085 is the product NDC for Tobramycin, Tobramycin 300 mg/5mL solution, listed with the FDA by Teva Pharmaceuticals USA, Inc.. 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.
Who is the labeler?: Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tobramycin	Tobramycin 3 mg/mL	SolutionOphthalmic	Preferred Pharmaceuticals Inc.	68788-4149	68788-4149-05
Tobramycin	Tobramycin 3 mg/mL	Solution/ dropsOphthalmic	JVET PHARMACEUTICALS LLC	86211-110	86211-0110-01
Tobramycin	Tobramycin 300 mg/5mL	SolutionRespiratory (Inhalation)	Ritedose Pharmaceuticals, LLC	76204-029	76204-0029-56
Tobramycin	Tobramycin 300 mg/4mL	SolutionRespiratory (Inhalation)	NorthStar RxLLC	72603-630	72603-0630-56
Tobramycin	Tobramycin 300 mg/5mL	SolutionRespiratory (Inhalation)	NorthStar RxLLC	72603-430	72603-0430-56
Tobramycin	Tobramycin 300 mg/5mL	SolutionRespiratory (Inhalation)	American Health Packaging	60687-731	60687-0731-83
Tobramycin	Tobramycin sulfate 1.2 g/30mL	Injection, Powder, Lyophilized, For solutionIntravenous	Northstar Rx LLC	72603-160	72603-0160-06
Tobramycin	Tobramycin 3 mg/mL	Solution/ dropsOphthalmic	Belcher Pharmaceuticals, LLC	62250-110	62250-0110-01
Tobramycintobramycin solution	Tobramycin 300 mg/5mL	InhalantRespiratory (Inhalation)	Micro Labs Limited	42571-408	42571-0408-92
Tobramycin	Tobramycin 300 mg/5mL	SolutionRespiratory (Inhalation)	Lifestar Pharma LLC	70756-604	70756-0604-56

All 56 Tobramycin NDCs