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

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	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 Inhalation Solution
Listing expiration: 2027-12-31

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e8983096-65e6-41f2-8b6f-bbf0a7227307	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
8403000c-b49c-4c60-bc4f-7a7024bef77c	Product name	2	20221213
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64281-110-05	Provocholine Inhalation Solution	1 in 1 CARTON	KIT	1	27
64281-110-05	Provocholine Inhalation Solution	6 in 1 PACKAGE	KIT	6	27
64281-110-06	Provocholine Inhalation Solution	6 in 1 PACKAGE	KIT	6	27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64281-110-05	ML - Milliliter	64281-110	38dc2b02-ab40-4911-b283-419d02c1b7f9	1	2022-10-06
64281-110-06	ML - Milliliter	64281-110	3acbbd00-9f20-4dbf-becf-460bbaca4a83	1	2022-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
METHACHOLINE CHLORIDE	ACTIVE INGREDIENT	0W5ETF9M2K	PROVOCHOLINE (METHACHOLINE CHLORIDE) POWDER, FOR SOLUTION [METHAPHARM INC.]	2
METHACHOLINE	ACTIVE MOIETY	03V657ZD3V	PROVOCHOLINE (METHACHOLINE CHLORIDE) POWDER, FOR SOLUTION [METHAPHARM INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64281-110	PROVOCHOLINE (METHACHOLINE CHLORIDE) POWDER, FOR SOLUTION PROVOCHOLINE INHALATION SOLUTION (METHACHOLINE CHLORIDE INHALATION SOLUTION) KIT [METHAPHARM INC.]	21	Current NDC, Legacy NDC, 3 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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Provocholine	METHACHOLINE CHLORIDE	Methapharm Inc.	e8983096-65e6-41f2-8b6f-bbf0a7227307	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019193 application number: NDA019193 ndc (product): 64281-110

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64281-110-05	64281011005	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, P	6 carton	2022-03-03	0000-00-00	No	No	Current
64281-110-06	64281011006	6 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 package	2022-07-14	0000-00-00	No	No	Current