What is NDC 66993-195?

66993-195 is the product NDC for Tobramycin Inhalation, Tobramycin 300 mg/4mL solution, listed with the FDA by Prasco, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Prasco, LLC, NDC labeler code 66993. 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 Inhalation?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tobramycin Inhalation NDC 66993-195

NDC codes

FDA NDC Directory

Product NDC (as listed)66993-195Labeler and product segments. Claims need a package NDC.

Product NDC at billing width66993-0195Add 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
66993-195-94	6699301959466993019594	14 POUCH in 1 CARTON (66993-195-94) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULEMarketed from Sep 15, 2020

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 Inhalation
Generic name (nonproprietary): tobramycin inhalation
Active ingredients: Tobramycin — 300 mg/4mL
Dosage form: Solution
Route: Respiratory (Inhalation)
Labeler: Prasco, LLCNDC labeler code 66993
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 201820
Marketing start: Sep 15, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 66993-195_43a62e66-8821-40b6-85dd-0f29fe4adc8cSPL ID 43a62e66-8821-40b6-85dd-0f29fe4adc8cSPL set ID b5b51665-c427-42b9-bd6e-6e3c06f650e1RxCUI 1314763UNII 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

N466993019594 followed by a unit qualifier and the quantity

Package 66993-0195-94. 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 Feb 24, 2023.

Indications (excerpt from the label)

Tobramycin Inhalation Solution is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa . Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV 1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies ( 14 )] . Tobramycin Inhalation Solution is an inhaled aminoglycoside antibacterial indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa . ( 1 ) Safety and efficacy have not been demonstrated in patients under the age of six years, patients with a forced expiratory volume in one second (FEV 1 ) less than 40% or greater than…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 66993-195

What is NDC 66993-195?: 66993-195 is the product NDC for Tobramycin Inhalation, Tobramycin 300 mg/4mL solution, listed with the FDA by Prasco, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tobramycin Inhalation.
What is the active ingredient?: Tobramycin.
Who is the labeler?: Prasco, LLC, NDC labeler code 66993. 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 Inhalation?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 201820

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

FDA NDC Directory listings under NDA 201820
Product	Strength	Form · route	Labeler	Product NDC
Bethkistobramycin	Tobramycin 300 mg/4mL	SolutionRespiratory (Inhalation)	Chiesi USA, Inc.	10122-820