What is NDC 10122-820?

10122-820 is the product NDC for Bethkis (tobramycin), Tobramycin 300 mg/4mL solution, listed with the FDA by Chiesi USA, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Chiesi USA, Inc., NDC labeler code 10122. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Bethkis?

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.

Bethkis NDC 10122-820 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)10122-820Labeler and product segments. Claims need a package NDC.

Product NDC at billing width10122-0820Add 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
10122-820-04	1012208200410122082004	4 AMPULE in 1 POUCH (10122-820-04) / 4 mL in 1 AMPULEMarketed from Apr 15, 2013
10122-820-28	1012208202810122082028	7 POUCH in 1 CARTON (10122-820-28) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULEMarketed from Apr 15, 2013
10122-820-56	1012208205610122082056	14 POUCH in 1 CARTON (10122-820-56) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULEMarketed from Apr 15, 2013

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): Bethkis
Generic name (nonproprietary): tobramycin
Active ingredients: Tobramycin — 300 mg/4mL
Dosage form: Solution
Route: Respiratory (Inhalation)
Labeler: Chiesi USA, Inc.NDC labeler code 10122
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 201820
Marketing start: Apr 15, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 10122-820_32442297-00c4-4800-b7c4-1e2e290f3162SPL ID 32442297-00c4-4800-b7c4-1e2e290f3162SPL set ID 1cd3d47b-025f-4705-9daf-cf07725ec223RxCUI 1314763, 1314768UNII 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

N410122082004 followed by a unit qualifier and the quantity

Package 10122-0820-04. 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)

BETHKIS 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 )] . BETHKIS 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 80% predicted, or patients colonized with Bur…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 10122-820

What is NDC 10122-820?: 10122-820 is the product NDC for Bethkis (tobramycin), Tobramycin 300 mg/4mL solution, listed with the FDA by Chiesi USA, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Bethkis (Tobramycin).
What is the active ingredient?: Tobramycin.
Who is the labeler?: Chiesi USA, Inc., NDC labeler code 10122. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Bethkis?: 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
Tobramycin Inhalation	Tobramycin 300 mg/4mL	SolutionRespiratory (Inhalation)	Prasco, LLC	66993-195

Bethkis (Tobramycin) NDC 10122-820