Icatibant

Product NDC: 63323-574
11-digit product format: 633230574
Labeler code: 63323
Product ID: 63323-574_d1c9afa7-c4ac-4739-85f1-2ae82440210c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Icatibant
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA208317
Marketing category: ANDA
Marketing start: 2020-11-15
Substance: ICATIBANT ACETATE
Active strength: 10 mg/mL
Pharmacologic classes: Bradykinin B2 Receptor Antagonist [EPC], Bradykinin B2 Receptor Antagonists [MoA]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208317-001	ICATIBANT ACETATE	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP		2020-06-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208317-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208317-001	ICATIBANT ACETATE	EQ 30MG BASE/3ML (EQ 10MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	AP	2020-06-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208317-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208317-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208317-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208317-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208317-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208317-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208317-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208317-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208317-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208317-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208317-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208317-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208317-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208317-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208317-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208317-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208317-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208317-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208317-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208317-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208317-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208317-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208317-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208317-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208317-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208317-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208317-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208317-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208317-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208317-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208317-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208317-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208317-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208317-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208317-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208317-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208317-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208317-001	AP	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ICATIBANT ACETATE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
325O8467XK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1148141	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
52c12c15-c00b-4efc-952d-1425c907706a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
94785027-dc4b-8998-43d4-c818590b3995	Product name	6	20241008
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63323-574-01	Icatibant	3 mL in 1 SYRINGE	INJECTION, SOLUTION	3	4
63323-574-86	Icatibant	1 in 1 CARTON	INJECTION, SOLUTION	1	4
63323-574-93	Icatibant	1 in 1 CARTON	INJECTION, SOLUTION	1	4
63323-574-93	Icatibant	3 in 1 BOX	INJECTION, SOLUTION	3	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-574	ICATIBANT (ICATIBANT) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]	4	Current NDC, Legacy NDC, 4 package rows	20240106_52c12c15-c00b-4efc-952d-1425c907706a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Icatibant	ICATIBANT	Fresenius Kabi USA, LLC	52c12c15-c00b-4efc-952d-1425c907706a	2023-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208317 application number: ANDA208317 ndc (product): 63323-574

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1148141	icatibant 30 MG in 3 ML Prefilled Syringe	PSN	52c12c15-c00b-4efc-952d-1425c907706a	4
1148141	3 ML icatibant 10 MG/ML Prefilled Syringe	SCD	52c12c15-c00b-4efc-952d-1425c907706a	4
1148141	icatibant (as icatibant acetate) 30 MG per 3 ML Prefilled Syringe	SY	52c12c15-c00b-4efc-952d-1425c907706a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-574-01	63323057401	3 mL in 1 SYRINGE	3 ml					Historical
63323-574-86	63323057486	1 SYRINGE in 1 CARTON (63323-574-86) / 3 mL in 1 SYRINGE (63323-574-01)	1 syringe	2020-11-15	0000-00-00	No	No	Current
63323-574-93	63323057493	3 CARTON in 1 BOX (63323-574-93) / 1 SYRINGE in 1 CARTON / 3 mL in 1 SYRINGE	3 carton	2020-11-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Icatibant	Fresenius Kabi USA, LLC \| Fresenius Kabi Austria	2023-11-08	HUMAN PRESCRIPTION DRUG LABEL	4