Glucagon

Product NDC: 63323-596
11-digit product format: 633230596
Labeler code: 63323
Product ID: 63323-596_9e17207f-b348-4be8-8416-2f0aa1392390
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glucagon
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: NDA201849
Marketing category: NDA
Marketing start: 2015-05-08
Substance: GLUCAGON HYDROCHLORIDE
Active strength: 1 mg/mL
Pharmacologic classes: Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
N201849-001	GLUCAGON	GLUCAGON HYDROCHLORIDE	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS		RLD, RS	2015-05-08
N201849-002	GLUCAGON	GLUCAGON HYDROCHLORIDE	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2019-09-19

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	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201849-002	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2019-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201849-002	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2019-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201849-002	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2019-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201849-002	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2019-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201849-002	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2019-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201849-002	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2019-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201849-002	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2019-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201849-002	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2019-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201849-002	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2019-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201849-002	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2019-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N201849-002	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2019-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201849-002	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2019-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201849-002	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2019-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201849-002	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2019-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N201849-002	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	2019-09-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201849-001	GLUCAGON	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	2015-05-08	`c0c555d07b60…`

Additional Listing Data#

Finished product: Yes
Brand name base: Glucagon
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLUCAGON HYDROCHLORIDE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1H87NVF4DB	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310497	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8c8acad6-44cc-43aa-966b-027e053be8f5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
83f7a8cc-8fbf-4478-9a44-b6214b840d9a	Product name	2	20250812
1e832aa0-608b-424f-9ced-615cef2ff5c5	Product name	1	20200220
6ee0758f-9a1a-41ee-90c4-3adce06b52b4	Product name	1	20191120
750a4794-c0e1-4ac9-9af5-006ecec3bb04	Product name	1	20150608

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63323-596-11	Glucagon	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	1	7
63323-596-13	Glucagon	10 in 1 TRAY	INJECTION, POWDER, LYOPHILIZED,	10	7
63323-596-08	Glucagon	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	1	6
63323-596-16	Glucagon	10 in 1 TRAY	INJECTION, POWDER, LYOPHILIZED,	10	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-596-08	EA - Each	63323-596	fe2f13d2-b25a-41e9-8f9e-0bb3462b9d68	1	2022-10-06
63323-596-11	EA - Each	63323-596	037fd4b8-d779-4b81-9b86-3e6be92e4578	1	2023-03-13
63323-596-13	EA - Each	63323-596	eb692baf-7a37-49d4-83dc-af1f928cbe4d	1	2015-06-09
63323-596-16	EA - Each	63323-596	5cb3c2fe-c644-4772-975f-ef574abc9f1e	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLUCAGON HYDROCHLORIDE	ACTIVE INGREDIENT	1H87NVF4DB	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
GLUCAGON HYDROCHLORIDE	ACTIVE INGREDIENT	1H87NVF4DB	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
GLUCAGON	ACTIVE MOIETY	76LA80IG2G	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
GLUCAGON	ACTIVE MOIETY	76LA80IG2G	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-596	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GLUCAGON KIT [FRESENIUS KABI USA, LLC]	7	Current NDC, Legacy NDC, 2 package rows	20211118_e4be1c0e-0fe6-45a0-9229-5cde98434b84.zip
63323-596	GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GLUCAGON KIT [FRESENIUS KABI USA, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20220420_8c8acad6-44cc-43aa-966b-027e053be8f5.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glucagon	GLUCAGON	Fresenius Kabi USA, LLC	c5c431b4-5618-4ff4-954e-4c0fbfed67b6	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201849 application number: NDA201849
GLUCAGON	GLUCAGON	HF Acquisition Co LLC, DBA HealthFirst	a0845f53-edad-e28f-e053-2995a90a31cf	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201849 application number: NDA201849
Glucagon	GLUCAGON	Fresenius Kabi USA, LLC	8c8acad6-44cc-43aa-966b-027e053be8f5	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201849 application number: NDA201849 ndc (product): 63323-596
Glucagon	GLUCAGON	Fresenius Kabi USA, LLC	e4be1c0e-0fe6-45a0-9229-5cde98434b84	2020-09-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201849 application number: NDA201849 ndc (product): 63323-596

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1H87NVF4DB	GLUCAGON HYDROCHLORIDE	19179-82-9	GLUCAGON HYDROCHLORIDE
76LA80IG2G	GLUCAGON	16941-32-5	Glucagon

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310497	glucagon (rDNA) 1 MG Injection	PSN	e4be1c0e-0fe6-45a0-9229-5cde98434b84	7
310497	glucagon (rDNA) 1 MG Injection	SCD	e4be1c0e-0fe6-45a0-9229-5cde98434b84	7
310497	glucagon (rDNA) 1 MG Injection	PSN	8c8acad6-44cc-43aa-966b-027e053be8f5	6
310497	glucagon (rDNA) 1 MG Injection	SCD	8c8acad6-44cc-43aa-966b-027e053be8f5	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-596-08	63323059608	1 mL in 1 VIAL, SINGLE-DOSE	1 ml					Historical
63323-596-11	63323059611	1 mL in 1 VIAL, SINGLE-DOSE	1 ml					Historical
63323-596-13	63323059613	10 VIAL, SINGLE-DOSE in 1 TRAY (63323-596-13) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-596-11)		2015-05-08	0000-00-00	No	No	Current
63323-596-16	63323059616	10 VIAL, SINGLE-DOSE in 1 TRAY (63323-596-16) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-596-08)		2015-05-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glucagon	Fresenius Kabi USA, LLC	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	6
Glucagon	Fresenius Kabi USA, LLC	2020-09-16	HUMAN PRESCRIPTION DRUG LABEL	7