Zegalogue

Product NDC: 80644-0013
11-digit product format: 806440013
Labeler code: 80644
Product ID: 80644-0013_ed6f6c3a-a8ea-7c74-e053-2a95a90a232b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dasiglucagon
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Zealand Pharma US, Inc
Application: NDA214231
Marketing category: NDA
Marketing start: 2021-04-05
Marketing end: 0000-00-00
Substance: DASIGLUCAGON
Active strength: 1 mg/.6mL
Pharmacologic classes: Antihypoglycemic Agent [EPC], Glucagon Receptor Agonists [MoA], Increased Glycogenolysis [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	80644-0013		D	Discontinued by firm	2026-08-17
excluded package	package	80644-0013	80644-0013-1	D	Discontinued by firm	2026-08-17
excluded package	package	80644-0013	80644-0013-2	D	Discontinued by firm	2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N214231-001	ZEGALOGUE	DASIGLUCAGON HYDROCHLORIDE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD	2021-03-22
N214231-002	ZEGALOGUE (AUTOINJECTOR)	DASIGLUCAGON HYDROCHLORIDE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD	2021-03-22

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214231-001	11795204	2034-01-06	U-3752		2023-11-24
N214231-001	10442847	2035-03-22		Drug substance, Drug product	2021-04-21
N214231-002	11795204	2034-01-06	U-3752		2023-11-24
N214231-002	10442847	2035-03-22		Drug substance, Drug product	2021-04-21

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214231-001	NCE	2026-03-22
N214231-001	NPP	2029-06-18
N214231-002	NCE	2026-03-22
N214231-002	NPP	2029-06-18

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 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD	2021-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD	2021-03-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 106 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214231-001	11795204	2034-01-06	U-3752		2023-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214231-001	10442847	2035-03-22		Drug substance, Drug product	2021-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214231-002	11795204	2034-01-06	U-3752		2023-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214231-002	10442847	2035-03-22		Drug substance, Drug product	2021-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214231-001	11795204	2034-01-06	U-3752		2023-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214231-001	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214231-002	11795204	2034-01-06	U-3752		2023-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214231-002	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214231-001	11795204	2034-01-06	U-3752		2023-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214231-001	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214231-002	11795204	2034-01-06	U-3752		2023-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214231-002	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214231-001	11795204	2034-01-06	U-3752		2023-11-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214231-001	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214231-002	11795204	2034-01-06	U-3752		2023-11-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214231-002	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214231-001	11795204	2034-01-06	U-3752		2023-11-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214231-001	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214231-002	11795204	2034-01-06	U-3752		2023-11-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214231-002	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214231-001	11795204	2034-01-06	U-3752		2023-11-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214231-001	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214231-002	11795204	2034-01-06	U-3752		2023-11-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214231-002	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214231-001	11795204	2034-01-06	U-3752		2023-11-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214231-001	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214231-002	11795204	2034-01-06	U-3752		2023-11-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214231-002	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214231-001	11795204	2034-01-06	U-3752		2023-11-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214231-001	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214231-002	11795204	2034-01-06	U-3752		2023-11-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214231-002	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214231-001	11795204	2034-01-06	U-3752		2023-11-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214231-001	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214231-002	11795204	2034-01-06	U-3752		2023-11-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214231-002	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214231-001	11795204	2034-01-06	U-3752		2023-11-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214231-001	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214231-002	11795204	2034-01-06	U-3752		2023-11-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214231-002	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`d8e5a09893c0…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N214231-001	NCE	2026-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214231-001	NPP	2029-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214231-002	NCE	2026-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214231-002	NPP	2029-06-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214231-001	NCE	2026-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214231-002	NCE	2026-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214231-001	NCE	2026-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214231-002	NCE	2026-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214231-001	NCE	2026-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214231-002	NCE	2026-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214231-001	NCE	2026-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214231-002	NCE	2026-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214231-001	NCE	2026-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214231-002	NCE	2026-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214231-001	NCE	2026-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214231-002	NCE	2026-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214231-001	NCE	2026-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214231-002	NCE	2026-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214231-001	NCE	2026-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214231-002	NCE	2026-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214231-001	NCE	2026-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214231-002	NCE	2026-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214231-001	NCE	2026-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214231-002	NCE	2026-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214231-001	NCE	2026-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214231-002	NCE	2026-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214231-001	NCE	2026-03-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214231-002	NCE	2026-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214231-001	NCE	2026-03-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214231-002	NCE	2026-03-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214231-001	NCE	2026-03-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214231-002	NCE	2026-03-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214231-001	NCE	2026-03-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214231-002	NCE	2026-03-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214231-001	NCE	2026-03-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N214231-002	NCE	2026-03-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214231-001	NCE	2026-03-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N214231-002	NCE	2026-03-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214231-001	NCE	2026-03-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N214231-002	NCE	2026-03-22	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
e737036e-16df-4168-8e18-c64b8deb5312	Product name	1	20210916

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80644-0013-1	ML - Milliliter	80644-0013	531bc32e-9d73-4644-bdba-a27dc6750eeb	1	2021-05-05
80644-0013-2	ML - Milliliter	80644-0013	6bce9cd4-eb28-4555-b206-94f27cd2bbe0	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80644-0013	ZEGALOGUE (DASIGLUCAGON) INJECTION, SOLUTION [ZEALAND PHARMA US, INC]	9	Legacy NDC	20250101_c6c32b47-c47c-4a7f-8d4d-23578f663217.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
Zegalogue	DASIGLUCAGON	Novo Nordisk	14704879-872c-4967-8779-04a3bbdfb4e6	2023-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214231 application number: NDA214231

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
AD4J2O47FQ	DASIGLUCAGON	1544300-84-6	DASIGLUCAGON

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80644-0013-1	80644001301	1 CONTAINER in 1 PACKAGE (80644-0013-1) > 1 SYRINGE, GLASS in 1 CONTAINER > .6 mL in 1 SYRINGE, GLASS	1 container	2021-04-05	0000-00-00	No	No	Current
80644-0013-2	80644001302	2 PACKAGE in 1 CARTON (80644-0013-2) > 1 CONTAINER in 1 PACKAGE > 1 SYRINGE, GLASS in 1 CONTAINER > .6 mL in 1 SYRINGE, GLASS	2 package	2021-04-05	0000-00-00	No	No	Current