What is NDC 70644-899?

70644-899 is the product NDC for Tobramycin Inhalation Solution Pak, Tobramycin 300 mg/5mL solution, listed with the FDA by Genericus, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Tobramycin Inhalation Solution Pak (Tobramycin).

Genericus, Inc., NDC labeler code 70644. 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 Solution Pak?

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 Solution Pak NDC 70644-899

NDC codes

FDA NDC Directory

Product NDC (as listed)70644-899Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70644-0899Add 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
70644-899-99	7064408999970644089999	14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULEMarketed from Jul 11, 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 Inhalation Solution PakSuffix: Inhalation Solution Pak
Generic name (nonproprietary): tobramycin
Active ingredients: Tobramycin — 300 mg/5mL
Dosage form: Solution
Route: Respiratory (Inhalation)
Labeler: Genericus, Inc.NDC labeler code 70644
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 205433
Marketing start: Jul 11, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Aminoglycosides (Chemical structure)
Identifiers: Product ID 70644-899_aeeb7c89-484f-4429-a5d5-0025d19745fdSPL ID aeeb7c89-484f-4429-a5d5-0025d19745fdSPL set ID dad13445-f591-4829-96f9-1598ba03dff8RxCUI 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

N470644089999 followed by a unit qualifier and the quantity

Package 70644-0899-99. 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 Dec 13, 2024.

Indications (excerpt from the label)

TOBRAMYCIN INHALATION SOLUTION PAK (co-packaging of tobramycin inhalation solution and PARI LC PLUS Reusable Nebulizer) is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with P. aeruginosa . Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV 1 < 25% or > 75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies ( 14 )]. TOBRAMYCIN INHALATION SOLUTION PAK contains tobramycin, an aminoglycoside antibacterial drug indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa ( 1 ).…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70644-899

What is NDC 70644-899?: 70644-899 is the product NDC for Tobramycin Inhalation Solution Pak, Tobramycin 300 mg/5mL solution, listed with the FDA by Genericus, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tobramycin Inhalation Solution Pak (Tobramycin).
What is the active ingredient?: Tobramycin.
Who is the labeler?: Genericus, Inc., NDC labeler code 70644. 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 Solution Pak?: 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 205433

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

FDA NDC Directory listings under NDA 205433
Product	Strength	Form · route	Labeler	Product NDC
Kitabis Paktobramycin	Tobramycin 300 mg/5mL	SolutionRespiratory (Inhalation)	Pari Respiratory Equipment, Inc.	24492-850

Tobramycin Inhalation Solution Pak (Tobramycin) NDC 70644-899