Application 201849

Type: NDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLUCAGON	GLUCAGON HYDROCHLORIDE	POWDER;INTRAMUSCULAR, INTRAVENOUS	EQ 1MG BASE/VIAL	Yes	Yes
002	GLUCAGON	GLUCAGON HYDROCHLORIDE	POWDER;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	EQ 1MG BASE/VIAL	Yes	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…`

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 ndc (product): 63323-582
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 ndc (product): 51662-1498
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): 63323-594 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): 63323-593 ndc (product): 63323-596

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51662-1498	GLUCAGON	GLUCAGON	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
63323-582	Glucagon	Glucagon	Fresenius Kabi USA, LLC	NDA	Current
63323-582	Glucagon	Glucagon	Fresenius Kabi USA, LLC	NDA	Current
63323-593	Glucagon	Glucagon	Fresenius Kabi USA, LLC	NDA	Current
63323-593	Glucagon	Glucagon	Fresenius Kabi USA, LLC	NDA	Current
63323-593	Glucagon	Glucagon	Fresenius Kabi USA, LLC	NDA	Current
63323-593	Glucagon	Glucagon	Fresenius Kabi USA, LLC	NDA	Current
63323-594	Glucagon	Glucagon	Fresenius Kabi USA, LLC	NDA	Current
63323-594	Glucagon	Glucagon	Fresenius Kabi USA, LLC	NDA	Current
63323-594	Glucagon	Glucagon	Fresenius Kabi USA, LLC	NDA	Current
63323-594	Glucagon	Glucagon	Fresenius Kabi USA, LLC	NDA	Current
63323-594	Glucagon	Glucagon	Fresenius Kabi USA, LLC	NDA	Current
63323-596	Glucagon	Glucagon	Fresenius Kabi USA, LLC	NDA	Current
63323-596	Glucagon	Glucagon	Fresenius Kabi USA, LLC	NDA	Current
63323-596	Glucagon	Glucagon	Fresenius Kabi USA, LLC	NDA	Current
63323-596	Glucagon	Glucagon	Fresenius Kabi USA, LLC	NDA	Current
63323-596	Glucagon	Glucagon	Fresenius Kabi USA, LLC	NDA	Current
63323-596	Glucagon	Glucagon	Fresenius Kabi USA, LLC	NDA	Current
63323-596	Glucagon	Glucagon	Fresenius Kabi USA, LLC	NDA	Current
63323-596	Glucagon	Glucagon	Fresenius Kabi USA, LLC	NDA	Current
63323-596	Glucagon	Glucagon	Fresenius Kabi USA, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83367	SUPPL	2025-09-17
83364	SUPPL	2025-09-17
71574	SUPPL	2022-07-15
71557	SUPPL	2022-07-15
68263	SUPPL	2021-08-02
68257	SUPPL	2021-08-02
59975	SUPPL	2019-09-11
59966	SUPPL	2019-09-11
22863	ORIG	2016-05-25
19036	SUPPL	2015-12-02
9934	SUPPL	2015-12-02
32142	ORIG	2015-05-13