Icatibant

Product NDC: 54092-135
Requested package NDC: 54092-135-01
11-digit product format: 540920135
Labeler code: 54092
Product ID: 54092-135_e2a326de-81cc-4931-824d-53ffc12582fd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Icatibant
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Takeda Pharmaceuticals America, Inc.
Application: NDA022150
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2019-07-30
Marketing end: 0000-00-00
Substance: ICATIBANT ACETATE
Active strength: 30 mg/3mL
Pharmacologic classes: Bradykinin B2 Receptor Antagonist [EPC], Bradykinin B2 Receptor Antagonists [MoA]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	54092-135	54092-135-01	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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022150-001	FIRAZYR	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N022150-001	AP

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2011-08-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022150-001	FIRAZYR	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2011-08-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022150-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022150-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022150-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022150-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022150-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022150-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022150-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022150-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022150-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022150-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022150-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022150-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022150-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022150-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022150-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022150-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022150-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022150-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022150-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022150-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022150-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022150-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022150-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022150-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022150-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022150-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022150-001	AP	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022150-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022150-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022150-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022150-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022150-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022150-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022150-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022150-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022150-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022150-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022150-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022150-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022150-001	AP	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022150-001	5648333	2019-07-15	U-1187	Drug substance, Drug product	2011-09-22	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022150-001	5648333	2019-07-15	U-1187	Drug substance, Drug product	2011-09-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022150-001	5648333	2019-07-15	U-1187	Drug substance, Drug product	2011-09-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022150-001	5648333	2019-07-15	U-1187	Drug substance, Drug product	2011-09-22	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54092-135-01	ML - Milliliter	54092-135	484a6a3e-8aef-4025-b01d-a9c3e7646b6e	1	2019-08-06
54092-135-02	ML - Milliliter	54092-135	516fb42f-a526-4396-b4c9-099da59625c6	1	2019-08-06

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
Firazyr	ICATIBANT ACETATE	Takeda Pharmaceuticals America, Inc.	ed6657ca-ab68-477a-9968-e12dc928b540	2025-07-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022150 application number: NDA022150

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
325O8467XK	ICATIBANT ACETATE	138614-30-9	ICATIBANT ACETATE
7PG89G35Q7	ICATIBANT	130308-48-4	Icatibant

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
54092-135-01	54092013501	1 SYRINGE, GLASS in 1 CARTON (54092-135-01) > 3 mL in 1 SYRINGE, GLASS	2019-07-30	0000-00-00	No	No	Current