Home NDC 64281-100 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 64281-100 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64281-100 64281-100-06 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019193-001 PROVOCHOLINE METHACHOLINE CHLORIDE 100MG/VIAL FOR SOLUTION / INHALATION RLD, RS 1986-10-31 N019193-002 PROVOCHOLINE METHACHOLINE CHLORIDE 1600MG/VIAL FOR SOLUTION / INHALATION RLD 2016-08-29
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N019193-001 PROVOCHOLINE 100MG/VIAL FOR SOLUTION / INHALATION RLD, RS 1986-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019193-002 PROVOCHOLINE 1600MG/VIAL FOR SOLUTION / INHALATION RLD 2016-08-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019193-001 PROVOCHOLINE 100MG/VIAL FOR SOLUTION / INHALATION RLD, RS 1986-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019193-002 PROVOCHOLINE 1600MG/VIAL FOR SOLUTION / INHALATION RLD 2016-08-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019193-001 PROVOCHOLINE 100MG/VIAL FOR SOLUTION / INHALATION RLD, RS 1986-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019193-002 PROVOCHOLINE 1600MG/VIAL FOR SOLUTION / INHALATION RLD 2016-08-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019193-001 PROVOCHOLINE 100MG/VIAL FOR SOLUTION / INHALATION RLD, RS 1986-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019193-002 PROVOCHOLINE 1600MG/VIAL FOR SOLUTION / INHALATION RLD 2016-08-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019193-001 PROVOCHOLINE 100MG/VIAL FOR SOLUTION / INHALATION RLD, RS 1986-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019193-002 PROVOCHOLINE 1600MG/VIAL FOR SOLUTION / INHALATION RLD 2016-08-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019193-001 PROVOCHOLINE 100MG/VIAL FOR SOLUTION / INHALATION RLD, RS 1986-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019193-002 PROVOCHOLINE 1600MG/VIAL FOR SOLUTION / INHALATION RLD 2016-08-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019193-001 PROVOCHOLINE 100MG/VIAL FOR SOLUTION / INHALATION RLD, RS 1986-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019193-002 PROVOCHOLINE 1600MG/VIAL FOR SOLUTION / INHALATION RLD 2016-08-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019193-001 PROVOCHOLINE 100MG/VIAL FOR SOLUTION / INHALATION RLD, RS 1986-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019193-002 PROVOCHOLINE 1600MG/VIAL FOR SOLUTION / INHALATION RLD 2016-08-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019193-001 PROVOCHOLINE 100MG/VIAL FOR SOLUTION / INHALATION RLD, RS 1986-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019193-002 PROVOCHOLINE 1600MG/VIAL FOR SOLUTION / INHALATION RLD 2016-08-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019193-001 PROVOCHOLINE 100MG/VIAL FOR SOLUTION / INHALATION RLD, RS 1986-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019193-002 PROVOCHOLINE 1600MG/VIAL FOR SOLUTION / INHALATION RLD 2016-08-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019193-001 PROVOCHOLINE 100MG/VIAL FOR SOLUTION / INHALATION RLD, RS 1986-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019193-002 PROVOCHOLINE 1600MG/VIAL FOR SOLUTION / INHALATION RLD 2016-08-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019193-001 PROVOCHOLINE 100MG/VIAL FOR SOLUTION / INHALATION RLD, RS 1986-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019193-002 PROVOCHOLINE 1600MG/VIAL FOR SOLUTION / INHALATION RLD 2016-08-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019193-001 PROVOCHOLINE 100MG/VIAL FOR SOLUTION / INHALATION RLD, RS 1986-10-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019193-002 PROVOCHOLINE 1600MG/VIAL FOR SOLUTION / INHALATION RLD 2016-08-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019193-001 PROVOCHOLINE 100MG/VIAL FOR SOLUTION / INHALATION RLD, RS 1986-10-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019193-002 PROVOCHOLINE 1600MG/VIAL FOR SOLUTION / INHALATION RLD 2016-08-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019193-001 PROVOCHOLINE 100MG/VIAL FOR SOLUTION / INHALATION RLD, RS 1986-10-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019193-002 PROVOCHOLINE 1600MG/VIAL FOR SOLUTION / INHALATION RLD 2016-08-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019193-001 PROVOCHOLINE 100MG/VIAL FOR SOLUTION / INHALATION RLD, RS 1986-10-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N019193-002 PROVOCHOLINE 1600MG/VIAL FOR SOLUTION / INHALATION RLD 2016-08-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019193-001 PROVOCHOLINE 100MG/VIAL FOR SOLUTION / INHALATION RLD, RS 1986-10-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N019193-002 PROVOCHOLINE 1600MG/VIAL FOR SOLUTION / INHALATION RLD 2016-08-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019193-001 PROVOCHOLINE 100MG/VIAL FOR SOLUTION / INHALATION RLD, RS 1986-10-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019193-002 PROVOCHOLINE 1600MG/VIAL FOR SOLUTION / INHALATION RLD 2016-08-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019193-001 PROVOCHOLINE 100MG/VIAL FOR SOLUTION / INHALATION RLD, RS 1986-10-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019193-002 PROVOCHOLINE 1600MG/VIAL FOR SOLUTION / INHALATION RLD 2016-08-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019193-001 PROVOCHOLINE 100MG/VIAL FOR SOLUTION / INHALATION RLD, RS 1986-10-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N019193-002 PROVOCHOLINE 1600MG/VIAL FOR SOLUTION / INHALATION RLD 2016-08-29 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base Provocholine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHACHOLINE CHLORIDE 100 mg/100mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0W5ETF9M2K Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64281-100-00 Provocholine 100 mg in 1 VIAL, GLASS POWDER, FOR SOLUTION 100 27 64281-100-06 Provocholine 6 in 1 BOX POWDER, FOR SOLUTION 6 27
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64281-100 PROVOCHOLINE (METHACHOLINE CHLORIDE) POWDER, FOR SOLUTION PROVOCHOLINE INHALATION SOLUTION (METHACHOLINE CHLORIDE INHALATION SOLUTION) KIT [METHAPHARM INC.] 21 Current NDC, Legacy NDC, 2 package rows 20250119_e8983096-65e6-41f2-8b6f-bbf0a7227307.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64281-100-00 64281010000 100 mg in 1 VIAL, GLASS 100 mg Historical 64281-100-06 64281010006 6 VIAL, GLASS in 1 BOX (64281-100-06) / 100 mg in 1 VIAL, GLASS (64281-100-00) 2013-03-27 0000-00-00 No No Current