NDC 64281-100
Provocholine
Methacholine Chloride
Provocholine is a Respiratory (inhalation) Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Methapharm Inc.. The primary component is Methacholine Chloride.
| Product ID | 64281-100_03d3bddd-b3f6-44d7-ad60-9217d0ecd93f |
| NDC | 64281-100 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Provocholine |
| Generic Name | Methacholine Chloride |
| Dosage Form | Powder, For Solution |
| Route of Administration | RESPIRATORY (INHALATION) |
| Marketing Start Date | 2013-03-27 |
| Marketing Category | NDA / NDA |
| Application Number | NDA019193 |
| Labeler Name | Methapharm Inc. |
| Substance Name | METHACHOLINE CHLORIDE |
| Active Ingredient Strength | 100 mg/100mg |
| Pharm Classes | Cholinergic Agonists [MoA],Cholinergic Receptor Agonist [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 64281-100-06
6 VIAL, GLASS in 1 BOX (64281-100-06) > 100 mg in 1 VIAL, GLASS (64281-100-00)
| Marketing Start Date | 2013-03-27 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 64281-100-00 [64281010000]
Provocholine POWDER, FOR SOLUTION
| Marketing Category | NDA |
| Application Number | NDA019193 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2013-03-27 |
NDC 64281-100-06 [64281010006]
Provocholine POWDER, FOR SOLUTION
| Marketing Category | NDA |
| Application Number | NDA019193 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2013-03-27 |
NDC 64281-100-16 [64281010016]
Provocholine POWDER, FOR SOLUTION
| Marketing Category | NDA |
| Application Number | NDA019193 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-04-23 |
| Marketing End Date | 2016-08-11 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| METHACHOLINE CHLORIDE | 100 mg/100mg |
OpenFDA Data
| SPL SET ID: | e8983096-65e6-41f2-8b6f-bbf0a7227307 |
| Manufacturer | |
| UNII | |
| UPC Code |
Pharmacological Class
- Cholinergic Agonists [MoA]
- Cholinergic Receptor Agonist [EPC]
Trademark Results [Provocholine]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROVOCHOLINE 73424769 1281245 Live/Registered |
Hoffmann-La Roche Inc. 1983-05-05 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.