What is NDC 83034-003?

83034-003 is the product NDC for Ohtuvayre (ensifentrine), Ensifentrine 3 mg/2.5mL suspension, listed with the FDA by MERCK SHARP & DOHME LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

MERCK SHARP & DOHME LLC, NDC labeler code 83034. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ohtuvayre?

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.

Ohtuvayre NDC 83034-003 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)83034-003Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83034-0003Add 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
83034-003-60	83034000360	60 POUCH in 1 CARTON (83034-003-60) / 1 AMPULE in 1 POUCH (83034-003-01) / 2.5 mL in 1 AMPULEMarketed from Jun 26, 2024
83034-003-65	83034000365	60 POUCH in 1 CARTON (83034-003-65) / 5 AMPULE in 1 POUCH (83034-003-05) / 2.5 mL in 1 AMPULEMarketed from Jun 26, 2024

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): Ohtuvayre
Generic name (nonproprietary): ensifentrine
Active ingredients: Ensifentrine — 3 mg/2.5mL
Dosage form: Suspension
Route: Respiratory (Inhalation)
Labeler: MERCK SHARP & DOHME LLCNDC labeler code 83034
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 217389
Marketing start: Jun 26, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Phosphodiesterase 3 Inhibitors (Mechanism)Phosphodiesterase 4 Inhibitors (Mechanism)
Identifiers: Product ID 83034-003_6806e1d0-c260-427f-b661-044ca81de168SPL ID 6806e1d0-c260-427f-b661-044ca81de168SPL set ID e6433c98-41a0-4f99-8f7f-d0e9db6e3f40RxCUI 2687221, 2687226UNII 3E3D8T1GIX
Pharmacologic class: Phosphodiesterase 3 Inhibitor; Phosphodiesterase 4 Inhibitor

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

N483034000360 followed by a unit qualifier and the quantity

Package 83034-0003-60. 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 Apr 23, 2026.

Indications (excerpt from the label)

OHTUVAYRE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. OHTUVAYRE is a phosphodiesterase 3 (PDE3) inhibitor and phosphodiesterase 4 (PDE4) inhibitor indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83034-003

What is NDC 83034-003?: 83034-003 is the product NDC for Ohtuvayre (ensifentrine), Ensifentrine 3 mg/2.5mL suspension, listed with the FDA by MERCK SHARP & DOHME LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ohtuvayre (Ensifentrine).
What is the active ingredient?: Ensifentrine.
Who is the labeler?: MERCK SHARP & DOHME LLC, NDC labeler code 83034. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ohtuvayre?: 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.

Ohtuvayre (Ensifentrine) NDC 83034-003