GlucaGen

Product NDC: 0597-0260
11-digit product format: 005970260
Labeler code: 0597
Product ID: 0597-0260_6f81fe64-66cb-4532-8fd0-932979b89b84
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: glucagon hydrochloride
Dosage form: KIT
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Application: NDA020918
Marketing category: NDA
Marketing start: 2005-06-22
Marketing end: 0000-00-00
Active strength: 0
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	0597-0260		D	Discontinued by firm		2026-08-17
excluded package	package	0597-0260	0597-0260-10	D	Discontinued by firm		2026-08-17

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 · 22 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	0597-0260-10	`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	0597-0260-10	`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	0597-0260-10	`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	0597-0260-10	`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	0597-0260-10	`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	0597-0260-10	`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	0597-0260-10	`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	0597-0260-10	`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	0597-0260-10	`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	0597-0260-10	`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	0597-0260-10	`367a005e9d99…`	`383a685ebd0f…`

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
N020918-001	GLUCAGEN	GLUCAGON HYDROCHLORIDE	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS		RLD	1998-06-22
N020918-002	GLUCAGEN	GLUCAGON HYDROCHLORIDE	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD	1998-06-22

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 · 58 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	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	1998-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	1998-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	1998-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	1998-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	1998-06-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	1998-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1998-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1998-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1998-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1998-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1998-06-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1998-06-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1998-06-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1998-06-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1998-06-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1998-06-22	`c0c555d07b60…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0597-0260-10	EA - Each	0597-0260	73a58ffc-266f-4eb5-8bad-578f98c5e001	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLUCAGON HYDROCHLORIDE	ACTIVE INGREDIENT	1H87NVF4DB	GLUCAGEN (GLUCAGON HYDROCHLORIDE) KIT GLUCAGEN (GLUCAGON HYDROCHLORIDE) INJECTION, POWDER, FOR SOLUTION [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
glucagon	ACTIVE MOIETY	76LA80IG2G	GLUCAGEN (GLUCAGON HYDROCHLORIDE) KIT GLUCAGEN (GLUCAGON HYDROCHLORIDE) INJECTION, POWDER, FOR SOLUTION [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLUCAGEN (GLUCAGON HYDROCHLORIDE) KIT GLUCAGEN (GLUCAGON HYDROCHLORIDE) INJECTION, POWDER, FOR SOLUTION [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1H87NVF4DB	GLUCAGON HYDROCHLORIDE	19179-82-9	glucagon hydrochloride

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0597-0260-10	00597026010	1 KIT in 1 KIT (0597-0260-10) * 1 mL in 1 VIAL, GLASS (0597-0053-01) * 1 mL in 1 VIAL, GLASS (0597-0265-94)	1 kit	2005-06-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GlucaGen	Boehringer Ingelheim Pharmaceuticals, Inc. \| Novo Nordisk \| Novo Nordisk A/S \| Catalent Belgium SA	2021-07-20	HUMAN PRESCRIPTION DRUG LABEL	9