Provocholine

Product NDC
64281-100
11-digit product format
642810100
Labeler code
64281
Product ID
64281-100_52a662b1-6841-8e8e-e063-6394a90a51e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methacholine chloride
Dosage form
POWDER, FOR SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Methapharm Inc.
Application
NDA019193
Marketing category
NDA
Marketing start
2013-03-27
Substance
METHACHOLINE CHLORIDE
Active strength
100 mg/100mg
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHACHOLINE CHLORIDE100 mg/100mg

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0W5ETF9M2K

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
8403000c-b49c-4c60-bc4f-7a7024bef77cProduct name220221213
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64281-100-00Provocholine100 mg in 1 VIAL, GLASSPOWDER, FOR SOLUTION10027
64281-100-06Provocholine6 in 1 BOXPOWDER, FOR SOLUTION627

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64281-100-06EA - Each64281-1007ab8cbd2-70a6-4db1-81cd-3675391a477612013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHACHOLINE CHLORIDEACTIVE INGREDIENT0W5ETF9M2KPROVOCHOLINE (METHACHOLINE CHLORIDE) POWDER, FOR SOLUTION [METHAPHARM INC.]2
METHACHOLINEACTIVE MOIETY03V657ZD3VPROVOCHOLINE (METHACHOLINE CHLORIDE) POWDER, FOR SOLUTION [METHAPHARM INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64281-100PROVOCHOLINE (METHACHOLINE CHLORIDE) POWDER, FOR SOLUTION PROVOCHOLINE INHALATION SOLUTION (METHACHOLINE CHLORIDE INHALATION SOLUTION) KIT [METHAPHARM INC.]21Current NDC, Legacy NDC, 2 package rows20250119_e8983096-65e6-41f2-8b6f-bbf0a7227307.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64281-100-0064281010000100 mg in 1 VIAL, GLASS100 mgHistorical
64281-100-06642810100066 VIAL, GLASS in 1 BOX (64281-100-06) / 100 mg in 1 VIAL, GLASS (64281-100-00) 2013-03-270000-00-00NoNoCurrent