ARIKAYCE

Product NDC: 71558-590
11-digit product format: 715580590
Labeler code: 71558
Product ID: 71558-590_9f8bbe4b-d496-41c7-85c6-470f0e83c2d1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amikacin
Dosage form: SUSPENSION
Route: RESPIRATORY (INHALATION)
Labeler: Insmed Incorporated
Application: NDA207356
Marketing category: NDA
Marketing start: 2018-10-12
Substance: AMIKACIN
Active strength: 590 mg/8.4mL
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	71558-590		U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71558-590	71558-590-28	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N207356-001	ARIKAYCE KIT	AMIKACIN SULFATE	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION		RLD, RS	2018-09-28

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207356-001	8632804	2026-12-05	U-2416		2018-10-24
N207356-001	8642075	2026-12-05		Drug product	2018-10-24
N207356-001	8679532	2026-12-05	U-2415		2018-10-24
N207356-001	8226975	2028-08-15		Drug product	2018-10-24
N207356-001	9566234	2034-01-18	U-2415	Drug product	2018-10-24
N207356-001	10251900	2035-05-15	U-2414		2019-05-02
N207356-001	10751355	2035-05-15	U-2414		2020-09-24
N207356-001	11446318	2035-05-15	U-2414		2022-10-14
N207356-001	12016873	2035-05-15	U-2414		2024-07-22
N207356-001	12168021	2035-05-15	U-2414		2025-01-15
N207356-001	12168022	2035-05-15	U-2414		2025-01-15
N207356-001	12377114	2035-05-15	U-2414		2025-08-20
N207356-001	12616708	2035-05-15	U-2414		2026-05-26
N207356-001	9895385	2035-05-15	U-2417		2018-10-24

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N207356-001	ODE-214	2025-09-28
N207356-001	GAIN	2030-09-28

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N207356-001	ARIKAYCE KIT	EQ 590MG BASE/8.4ML	SUSPENSION, LIPOSOMAL / INHALATION	RLD, RS	2018-09-28	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 486 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207356-001	8632804	2026-12-05	U-2416		2018-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	8642075	2026-12-05		Drug product	2018-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	8679532	2026-12-05	U-2415		2018-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	8226975	2028-08-15		Drug product	2018-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	9566234	2034-01-18	U-2415	Drug product	2018-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	10251900	2035-05-15	U-2414		2019-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	10751355	2035-05-15	U-2414		2020-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	11446318	2035-05-15	U-2414		2022-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	12016873	2035-05-15	U-2414		2024-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	12168021	2035-05-15	U-2414		2025-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	12168022	2035-05-15	U-2414		2025-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	12377114	2035-05-15	U-2414		2025-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	9895385	2035-05-15	U-2417		2018-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	7718189	2025-06-06	U-2415	Drug product	2018-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	8632804	2026-12-05	U-2416		2018-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	8642075	2026-12-05		Drug product	2018-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	8679532	2026-12-05	U-2415		2018-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	8226975	2028-08-15		Drug product	2018-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	9566234	2034-01-18	U-2415	Drug product	2018-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	10251900	2035-05-15	U-2414		2019-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	10751355	2035-05-15	U-2414		2020-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	11446318	2035-05-15	U-2414		2022-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	12016873	2035-05-15	U-2414		2024-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	12168021	2035-05-15	U-2414		2025-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	12168022	2035-05-15	U-2414		2025-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	12377114	2035-05-15	U-2414		2025-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	9895385	2035-05-15	U-2417		2018-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207356-001	7718189	2025-06-06	U-2415	Drug product	2018-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	8632804	2026-12-05	U-2416		2018-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	8642075	2026-12-05		Drug product	2018-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	8679532	2026-12-05	U-2415		2018-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	8226975	2028-08-15		Drug product	2018-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	9566234	2034-01-18	U-2415	Drug product	2018-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	10251900	2035-05-15	U-2414		2019-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	10751355	2035-05-15	U-2414		2020-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	11446318	2035-05-15	U-2414		2022-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	12016873	2035-05-15	U-2414		2024-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	12168021	2035-05-15	U-2414		2025-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	12168022	2035-05-15	U-2414		2025-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	9895385	2035-05-15	U-2417		2018-10-24	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207356-001	ODE-214	2025-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207356-001	GAIN	2030-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	ODE-214	2025-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207356-001	GAIN	2030-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207356-001	ODE-214	2025-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207356-001	GAIN	2030-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207356-001	ODE-214	2025-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207356-001	GAIN	2030-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207356-001	ODE-214	2025-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207356-001	GAIN	2030-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207356-001	ODE-214	2025-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207356-001	GAIN	2030-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207356-001	ODE-214	2025-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207356-001	GAIN	2030-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207356-001	ODE-214	2025-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207356-001	GAIN	2030-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207356-001	ODE-214	2025-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207356-001	GAIN	2030-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207356-001	ODE-214	2025-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207356-001	GAIN	2030-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207356-001	ODE-214	2025-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207356-001	GAIN	2030-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207356-001	ODE-214	2025-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207356-001	GAIN	2030-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207356-001	ODE-214	2025-09-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207356-001	GAIN	2030-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207356-001	ODE-214	2025-09-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207356-001	GAIN	2030-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207356-001	ODE-214	2025-09-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207356-001	GAIN	2030-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207356-001	ODE-214	2025-09-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207356-001	GAIN	2030-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207356-001	ODE-214	2025-09-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207356-001	GAIN	2030-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207356-001	ODE-214	2025-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207356-001	GAIN	2030-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207356-001	ODE-214	2025-09-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207356-001	GAIN	2030-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207356-001	ODE-214	2025-09-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207356-001	GAIN	2030-09-28	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: ARIKAYCE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMIKACIN	590 mg/8.4mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
84319SGC3C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2059184	Internal RxNorm lookup
2059189	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
499ab990-2b21-474f-aaba-d86388965f40	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e1d8d349-40e8-4ab6-9f36-aa84681732ed	Product name	3	20250124
7a2acf42-1a2f-4e31-9d74-f6d541e9bb46	Product name	1	20190111
37302fde-6a8c-4412-a7e0-b0fdb78cc567	Product name	1	20151215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71558-590-28	ARIKAYCE	28 in 1 CARTON	SUSPENSION	28		14
71558-590-28	ARIKAYCE	8.4 mL in 1 VIAL	SUSPENSION	8.4		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71558-590-28	ML - Milliliter	71558-590	c85f0a02-4202-4f5a-ad83-329bf89fd021	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71558-590	ARIKAYCE (AMIKACIN) SUSPENSION [INSMED INCORPORATED]	11	Current NDC, Legacy NDC, 2 package rows	20250327_499ab990-2b21-474f-aaba-d86388965f40.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
ARIKAYCE	AMIKACIN	Insmed Incorporated	499ab990-2b21-474f-aaba-d86388965f40	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 207356 application number: NDA207356 ndc (product): 71558-590

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
84319SGC3C	AMIKACIN	37517-28-5	AMIKACIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2059184	amikacin liposomal 590 MG in 8.4 ML Inhalation Suspension	PSN	499ab990-2b21-474f-aaba-d86388965f40	14
2059189	ARIKAYCE 590 MG in 8.4 ML Inhalation Suspension	PSN	499ab990-2b21-474f-aaba-d86388965f40	14
2059189	amikacin liposomal 70.3 MG/ML Inhalation Suspension [Arikayce]	SBD	499ab990-2b21-474f-aaba-d86388965f40	14
2059184	amikacin liposomal 70.3 MG/ML Inhalation Suspension	SCD	499ab990-2b21-474f-aaba-d86388965f40	14
2059184	amikacin liposomal 590 MG per 8.4 ML Inhalation Suspension	SY	499ab990-2b21-474f-aaba-d86388965f40	14
2059189	ARIKAYCE 590 MG per 8.4 ML Inhalation Suspension	SY	499ab990-2b21-474f-aaba-d86388965f40	14
2059189	Arikayce 70.3 MG/ML Inhalation Suspension	SY	499ab990-2b21-474f-aaba-d86388965f40	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71558-590-28	71558059028	28 VIAL in 1 CARTON (71558-590-28) / 8.4 mL in 1 VIAL	28 vial	2018-10-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ARIKAYCE	Insmed Incorporated \| ACS Dobfar S.p.A. \| Resilience Biotechnologies Inc. \| LabCorp Early Development Laboratories Limited \| Wickham Micro Limited \| Alcami Carolinas Corporation \| Sharp Packaging Services, LLC \| PPD Development Ireland Ltd \| Charles River Laboratories Ireland Limited \| Fisher Clinical Services Inc	2026-06-29	HUMAN PRESCRIPTION DRUG LABEL	16