Glycopyrrolate Inhalation Solution (25 µg/mL)

Manufacturer: Holopack Verpackungstechnik GmbH
Effective date: 2021-10-27
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 22:30:40

Label at a glance#

ProductLonhala

Active ingredientGLYCOPYRROLATE

Label structure2 sections

Label contents#

Full prescribing information#

Lonhala

SPL UNCLASSIFIED SECTION

(glycopyrrolate) inhalation solution, for oral inhalation use

PRINCIPAL DISPLAY PANEL - SHIPPER LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sunovion Pharmaceuticals Inc.

Marlborough, MA 01752 USA

Product of Finland

Lonhala® (Glycopyrrolate) Inhalation Solution (25 µg/mL)

Item No. 401732-001

Lot: ?????

Exp: 07-2020

Caution: For manufacturing, processing, or repacking.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]

432 pouches with two 1.0 ml ampoules each

Carton # ????

Shipping Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

Lonhala
Glycopyrrolate
SODIUM CHLORIDE
SODIUM HYDROXIDE
CITRIC ACID MONOHYDRATE
HYDROCHLORIC ACID
WATER
GLYCOPYRRONIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60940-024	60940-024-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
HYDROCHLORIC ACID	QTT17582CB	IACT
WATER	059QF0KO0R	IACT
GLYCOPYRROLATE	V92SO9WP2I	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208437-001	LONHALA MAGNAIR KIT	GLYCOPYRROLATE	25MCG/ML	SOLUTION / INHALATION		RLD	2017-12-05

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208437-001	11278683	2026-08-16		Drug product	2022-03-25
N208437-001	9265900	2028-12-07		Drug product	2018-01-02
N208437-001	10940110	2029-02-26	U-1773	Drug product	2021-03-16
N208437-001	9789270	2030-10-30		Drug product	2018-01-02
N208437-001	9168556	2032-09-01		Drug product	2018-01-02
N208437-001	9604018	2033-05-16		Drug product	2018-01-02
N208437-001	10376661	2035-09-14		Drug product	2019-09-05
N208437-001	10688518	2036-11-12		Drug product	2020-06-30
N208437-001	10744277	2036-12-07	U-2941	Drug product	2020-09-01

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD	2017-12-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208437-001	LONHALA MAGNAIR KIT	25MCG/ML	SOLUTION / INHALATION	RLD, RS	2017-12-05	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 482 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208437-001	11278683	2026-08-16		Drug product	2022-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208437-001	9265900	2028-12-07		Drug product	2018-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208437-001	10940110	2029-02-26	U-1773	Drug product	2021-03-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208437-001	9789270	2030-10-30		Drug product	2018-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208437-001	9168556	2032-09-01		Drug product	2018-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208437-001	9604018	2033-05-16		Drug product	2018-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208437-001	10376661	2035-09-14		Drug product	2019-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208437-001	10688518	2036-11-12		Drug product	2020-06-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208437-001	10744277	2036-12-07	U-2941	Drug product	2020-09-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208437-001	11278683	2026-08-16		Drug product	2022-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208437-001	9265900	2028-12-07		Drug product	2018-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208437-001	10940110	2029-02-26	U-1773	Drug product	2021-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208437-001	9789270	2030-10-30		Drug product	2018-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208437-001	9168556	2032-09-01		Drug product	2018-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208437-001	9604018	2033-05-16		Drug product	2018-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208437-001	10376661	2035-09-14		Drug product	2019-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208437-001	10688518	2036-11-12		Drug product	2020-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208437-001	10744277	2036-12-07	U-2941	Drug product	2020-09-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208437-001	11278683	2026-08-16		Drug product	2022-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208437-001	9265900	2028-12-07		Drug product	2018-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208437-001	10940110	2029-02-26	U-1773	Drug product	2021-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208437-001	9789270	2030-10-30		Drug product	2018-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208437-001	9168556	2032-09-01		Drug product	2018-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208437-001	9604018	2033-05-16		Drug product	2018-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208437-001	10376661	2035-09-14		Drug product	2019-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208437-001	10688518	2036-11-12		Drug product	2020-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208437-001	10744277	2036-12-07	U-2941	Drug product	2020-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208437-001	7931212	2025-11-25		Drug product	2018-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208437-001	11278683	2026-08-16		Drug product	2022-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208437-001	9265900	2028-12-07		Drug product	2018-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208437-001	10940110	2029-02-26	U-1773	Drug product	2021-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208437-001	9789270	2030-10-30		Drug product	2018-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208437-001	9168556	2032-09-01		Drug product	2018-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208437-001	9604018	2033-05-16		Drug product	2018-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208437-001	10376661	2035-09-14		Drug product	2019-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208437-001	10688518	2036-11-12		Drug product	2020-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208437-001	10744277	2036-12-07	U-2941	Drug product	2020-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208437-001	7931212	2025-11-25		Drug product	2018-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208437-001	11278683	2026-08-16		Drug product	2022-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208437-001	9265900	2028-12-07		Drug product	2018-01-02	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208437-001	NP	2020-12-05	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N208437-001	NP	2020-12-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208437-001	NP	2020-12-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208437-001	NP	2020-12-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208437-001	NP	2020-12-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208437-001	NP	2020-12-05	`ea99ee380514…`

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
cf5a7a5b-ae64-0c3f-e053-2a95a90a150a			de544612-9129-4b79-9aa9-0b06f059cb78	2021-10-27		Exact identifier spl id: cf5a7a5b-ae64-0c3f-e053-2a95a90a150a spl set id: de544612-9129-4b79-9aa9-0b06f059cb78

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.