What is NDC 64281-116?

64281-116 is the product NDC for Provocholine Inhalation Solution, Methacholine chloride 48 mg/3mL solution, listed with the FDA by Methapharm Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Provocholine Inhalation Solution (Methacholine Chloride Inhalation Solution).

Methapharm Inc., NDC labeler code 64281. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Provocholine Inhalation Solution?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Provocholine Inhalation Solution NDC 64281-116

NDC codes

FDA NDC Directory

Product NDC (as listed)64281-116Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64281-0116Add 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
64281-116-12	64281011612	2 CARTON in 1 CARTON (64281-116-12) / 6 VIAL, PLASTIC in 1 CARTON (64281-116-06) / 3 mL in 1 VIAL, PLASTIC (64281-116-00)Marketed from Apr 14, 2026

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): Provocholine Inhalation Solution
Generic name (nonproprietary): methacholine chloride inhalation solution
Active ingredients: Methacholine chloride — 48 mg/3mL
Dosage form: Solution
Route: Respiratory (Inhalation)
Labeler: Methapharm Inc.NDC labeler code 64281
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 019193
Marketing start: Apr 14, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Agonists (Mechanism)
Identifiers: Product ID 64281-116_58dbe037-e3e4-8394-e063-6394a90ab3fdSPL ID 58dbe037-e3e4-8394-e063-6394a90ab3fdSPL set ID e8983096-65e6-41f2-8b6f-bbf0a7227307UNII 0W5ETF9M2K
Pharmacologic class: Cholinergic Receptor Agonist

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

N464281011612 followed by a unit qualifier and the quantity

Package 64281-0116-12. 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 Jul 15, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Provocholine, used in a methacholine challenge test, is indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically apparent asthma. Provocholine, a cholinergic agonist used in a methacholine challenge test, is indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically apparent asthma (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64281-116

What is NDC 64281-116?: 64281-116 is the product NDC for Provocholine Inhalation Solution, Methacholine chloride 48 mg/3mL solution, listed with the FDA by Methapharm Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Provocholine Inhalation Solution (Methacholine Chloride Inhalation Solution).
What is the active ingredient?: Methacholine chloride.
Who is the labeler?: Methapharm Inc., NDC labeler code 64281. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Provocholine Inhalation Solution?: 1 other product NDC are listed under this name. See all Provocholine Inhalation Solution 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 Provocholine Inhalation Solution NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Provocholine Inhalation Solutionmethacholine chloride inhalation solution	—	Kit	Methapharm Inc.	64281-110	64281-0110-06

Other NDCs under NDA 019193

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

FDA NDC Directory listings under NDA 019193
Product	Strength	Form · route	Labeler	Product NDC
Provocholinemethacholine chloride	Methacholine chloride 100 mg/100mg	Powder, For solutionRespiratory (Inhalation)	Methapharm Inc.	64281-100
Provocholine Inhalation Solutionmethacholine chloride inhalation solution	—	Kit	Methapharm Inc.	64281-110