DARTISLA ODT

Product NDC: 82111-518
11-digit product format: 821110518
Labeler code: 82111
Product ID: 82111-518_b7fa57f9-9e30-4011-8e80-d2e5699d5b6a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glycopyrrolate Orally Disintegrating Tablets
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Edenbridge Pharmaceuticals LLC.
Application: NDA215019
Marketing category: NDA
Marketing start: 2022-02-01
Marketing end: 0000-00-00
Substance: GLYCOPYRROLATE
Active strength: 2 mg/1
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	82111-518		D	Discontinued by firm		2026-09-14
excluded package	package	82111-518	82111-518-01	D	Discontinued by firm		2026-09-14

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	82111-518-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	82111-518-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	82111-518-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	82111-518-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	82111-518-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	82111-518-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	82111-518-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	82111-518-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82111-518-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	82111-518-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	82111-518-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	82111-518-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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
N215019-001	DARTISLA ODT	GLYCOPYRROLATE	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2021-12-16
N215019-002	DARTISLA ODT	GLYCOPYRROLATE	0.85MG	TABLET, ORALLY DISINTEGRATING / ORAL			2023-10-11

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 · 54 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	N215019-001	DARTISLA ODT	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215019-002	DARTISLA ODT	0.85MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215019-001	DARTISLA ODT	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215019-002	DARTISLA ODT	0.85MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215019-001	DARTISLA ODT	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215019-002	DARTISLA ODT	0.85MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215019-001	DARTISLA ODT	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215019-002	DARTISLA ODT	0.85MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215019-001	DARTISLA ODT	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215019-002	DARTISLA ODT	0.85MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215019-001	DARTISLA ODT	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215019-002	DARTISLA ODT	0.85MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215019-001	DARTISLA ODT	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215019-002	DARTISLA ODT	0.85MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215019-001	DARTISLA ODT	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215019-002	DARTISLA ODT	0.85MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215019-001	DARTISLA ODT	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215019-002	DARTISLA ODT	0.85MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215019-001	DARTISLA ODT	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215019-002	DARTISLA ODT	0.85MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215019-001	DARTISLA ODT	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215019-002	DARTISLA ODT	0.85MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215019-001	DARTISLA ODT	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215019-002	DARTISLA ODT	0.85MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215019-001	DARTISLA ODT	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215019-002	DARTISLA ODT	0.85MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215019-001	DARTISLA ODT	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215019-002	DARTISLA ODT	0.85MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215019-001	DARTISLA ODT	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215019-002	DARTISLA ODT	0.85MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215019-001	DARTISLA ODT	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215019-002	DARTISLA ODT	0.85MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215019-001	DARTISLA ODT	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2021-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215019-001	DARTISLA ODT	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2021-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215019-001	DARTISLA ODT	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2021-12-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N215019-001	DARTISLA ODT	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2021-12-16	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215019-001	DARTISLA ODT	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-16	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215019-002	DARTISLA ODT	0.85MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215019-001	DARTISLA ODT	1.7MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-16	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N215019-002	DARTISLA ODT	0.85MG	TABLET, ORALLY DISINTEGRATING / ORAL		2023-10-11	`1c564ffb4f44…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82111-518-01	EA - Each	82111-518	012b59a9-2735-492c-ac1e-7d12ff2d838a	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82111-518	DARTISLA ODT (GLYCOPYRROLATE ORALLY DISINTEGRATING TABLETS) TABLET, ORALLY DISINTEGRATING [EDENBRIDGE PHARMACEUTICALS LLC.]	5	Legacy NDC	20231025_52daf47e-7ba3-4105-be7f-27001a87e16e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V92SO9WP2I	GLYCOPYRROLATE	51186-83-5	GLYCOPYRROLATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82111-518-01	82111051801	3 BLISTER PACK in 1 CARTON (82111-518-01) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	3 blister pack	2022-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glycopyrrolate Orally Disintegrating Tablets	Edenbridge Pharmaceuticals LLC.	2023-10-19	Human Prescription Drug Label	5