FDA.reportPublic FDA data

Provocholine Inhalation Solution

Product NDC
64281-110
11-digit product format
642810110
Labeler code
64281
Product ID
64281-110_52a662b1-6841-8e8e-e063-6394a90a51e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methacholine Chloride Inhalation Solution
Dosage form
KIT
Labeler
Methapharm Inc.
Application
NDA019193
Marketing category
NDA
Marketing start
2022-03-03
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

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
64281-110-05Provocholine Inhalation Solution1 in 1 CARTONKIT127
64281-110-05Provocholine Inhalation Solution6 in 1 PACKAGEKIT627
64281-110-06Provocholine Inhalation Solution6 in 1 PACKAGEKIT627

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64281-110-05ML - Milliliter64281-11038dc2b02-ab40-4911-b283-419d02c1b7f912022-10-06
64281-110-06ML - Milliliter64281-1103acbbd00-9f20-4dbf-becf-460bbaca4a8312022-10-06

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
64281-110PROVOCHOLINE (METHACHOLINE CHLORIDE) POWDER, FOR SOLUTION PROVOCHOLINE INHALATION SOLUTION (METHACHOLINE CHLORIDE INHALATION SOLUTION) KIT [METHAPHARM INC.]21Current NDC, Legacy NDC, 3 package rows20250119_e8983096-65e6-41f2-8b6f-bbf0a7227307.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64281-110-05642810110056 CARTON in 1 PACKAGE (64281-110-05) > 1 KIT in 1 CARTON * 1 VIAL, PLASTIC in 1 KIT > 3 mL in 1 VIAL, PLASTIC (64281-113-00) * 1 VIAL, PLASTIC in 1 KIT > 3 mL in 1 VIAL, PLASTIC (64281-115-00) * 1 VIAL, PLASTIC in 1 KIT > 3 mL in 1 VIAL, PLASTIC (64281-114-00) * 1 VIAL, PLASTIC in 1 KIT > 3 mL in 1 VIAL, PLASTIC (64281-116-00) * 1 VIAL, P6 carton2022-03-030000-00-00NoNoCurrent
64281-110-06642810110066 PACKAGE in 1 PACKAGE (64281-110-06) / 6 CARTON in 1 PACKAGE (64281-110-05) / 1 KIT in 1 CARTON * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-113-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-115-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-114-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-116-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-112-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-111-00) 6 package2022-07-140000-00-00NoNoCurrent