Application 012122

Type: NDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLUCAGON	GLUCAGON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	GLUCAGON	GLUCAGON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N012122-001	GLUCAGON	GLUCAGON HYDROCHLORIDE	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982
N012122-002	GLUCAGON	GLUCAGON HYDROCHLORIDE	EQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N012122-001	GLUCAGON	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N012122-002	GLUCAGON	EQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012122-001	GLUCAGON	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N012122-002	GLUCAGON	EQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012122-001	GLUCAGON	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N012122-002	GLUCAGON	EQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012122-001	GLUCAGON	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012122-002	GLUCAGON	EQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012122-001	GLUCAGON	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N012122-002	GLUCAGON	EQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012122-001	GLUCAGON	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N012122-002	GLUCAGON	EQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012122-001	GLUCAGON	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N012122-002	GLUCAGON	EQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012122-001	GLUCAGON	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N012122-002	GLUCAGON	EQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012122-001	GLUCAGON	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N012122-002	GLUCAGON	EQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012122-001	GLUCAGON	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N012122-002	GLUCAGON	EQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012122-001	GLUCAGON	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012122-002	GLUCAGON	EQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N012122-001	GLUCAGON	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N012122-002	GLUCAGON	EQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N012122-001	GLUCAGON	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N012122-002	GLUCAGON	EQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012122-001	GLUCAGON	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012122-002	GLUCAGON	EQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012122-001	GLUCAGON	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012122-002	GLUCAGON	EQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012122-001	GLUCAGON	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012122-002	GLUCAGON	EQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012122-001	GLUCAGON	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012122-002	GLUCAGON	EQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012122-001	GLUCAGON	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N012122-002	GLUCAGON	EQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012122-001	GLUCAGON	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N012122-002	GLUCAGON	EQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012122-001	GLUCAGON	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012122-002	GLUCAGON	EQ 10MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`3a93d1ddd44b…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glucagon	GLUCAGON	Amphastar Pharmaceuticals, Inc.	8cc40354-b5ac-45b6-a211-93b44444f2a3	2026-08-11	Warnings, Adverse reactions	Name fallback brand name: Glucagon
Glucagon	GLUCAGON	Sportpharm LLC	e3f65564-bd7c-4d51-8bef-4883cdc3d6a0	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: Glucagon
Glucagon	GLUCAGON	Sportpharm LLC	9d0fbe4e-6120-4f69-b06d-c939eaeb7708	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Glucagon
Glucagon	GLUCAGON	Sportpharm LLC	34c3c58a-3d17-4a12-b592-971bdd41aeca	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Glucagon
Glucagon	GLUCAGON	Cipla USA Inc.	6e80adb5-f45c-4f92-8dae-ee64217c676f	2025-10-07	Warnings, Adverse reactions	Name fallback brand name: Glucagon
GLUCAGON	GLUCAGON	Lupin Pharmaceuticals, Inc.	3d8c92cf-9263-4126-8a5b-4cd761e31bc1	2025-08-04	Warnings, Adverse reactions	Name fallback brand name: GLUCAGON
Glucagon	GLUCAGON	Fresenius Kabi USA, LLC	c5c431b4-5618-4ff4-954e-4c0fbfed67b6	2025-03-31	Warnings, Adverse reactions	Name fallback brand name: Glucagon
Glucagon	GLUCAGON	Mylan Pharmaceuticals Inc.	15b49500-0aae-4e25-9a1d-709983233cc6	2024-12-15	Warnings, Adverse reactions	Name fallback brand name: Glucagon
GLUCAGON	GLUCAGON	HF Acquisition Co LLC, DBA HealthFirst	a0845f53-edad-e28f-e053-2995a90a31cf	2024-02-22	Warnings, Adverse reactions	Name fallback brand name: GLUCAGON
Glucagon	GLUCAGON	A-S Medication Solutions	31105257-4af6-417e-9fb9-58a9b4e87092	2023-07-21	Warnings, Adverse reactions	Name fallback brand name: Glucagon
Glucagon	GLUCAGON	Fresenius Kabi USA, LLC	8c8acad6-44cc-43aa-966b-027e053be8f5	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Glucagon
Glucagon	GLUCAGON	Fresenius Kabi USA, LLC	e4be1c0e-0fe6-45a0-9229-5cde98434b84	2020-09-16	Warnings, Adverse reactions	Name fallback brand name: Glucagon

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.