Provocholine Inhalation Solution
- Product NDC
- 64281-116
- 11-digit product format
- 642810116
- Labeler code
- 64281
- Product ID
- 64281-116_52a662b1-6841-8e8e-e063-6394a90a51e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methacholine Chloride Inhalation Solution
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Methapharm Inc.
- Application
- NDA019193
- Marketing category
- NDA
- Marketing start
- 2026-04-14
- Substance
- METHACHOLINE CHLORIDE
- Active strength
- 48 mg/3mL
- Pharmacologic classes
- Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Provocholine Inhalation Solution
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHACHOLINE CHLORIDE | 48 mg/3mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0W5ETF9M2K |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64281-116-00 | Provocholine Inhalation Solution | 3 mL in 1 VIAL, PLASTIC | SOLUTION | 3 | | 27 |
| 64281-116-06 | Provocholine Inhalation Solution | 6 in 1 CARTON | SOLUTION | 6 | | 27 |
| 64281-116-12 | Provocholine Inhalation Solution | 2 in 1 CARTON | SOLUTION | 2 | | 27 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64281-116 | PROVOCHOLINE (METHACHOLINE CHLORIDE) POWDER, FOR SOLUTION PROVOCHOLINE INHALATION SOLUTION (METHACHOLINE CHLORIDE INHALATION SOLUTION) KIT [METHAPHARM INC.] | 21 | Current NDC, 3 package rows | 20250119_e8983096-65e6-41f2-8b6f-bbf0a7227307.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 64281-116-00 | 64281011600 | 3 mL in 1 VIAL, PLASTIC | 3 ml | | | | Historical |
| 64281-116-06 | 64281011606 | 6 in 1 CARTON | | | | | Historical |
| 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) | 2 carton | 2026-04-14 | No | No | Historical |