REDEMPLO

Product NDC: 84141-025
11-digit product format: 841410025
Labeler code: 84141
Product ID: 84141-025_4b987e0d-345d-4ba3-b5d6-d70c1bfe0fd7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: plozasiran
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Arrowhead Pharmaceuticals, Inc.
Application: NDA219947
Marketing category: NDA
Marketing start: 2025-11-19
Substance: PLOZASIRAN
Active strength: 25 mg/.5mL
Pharmacologic classes: APOC-III-directed RNA Interaction [EPC], Increased RNA Degradation [PE], RNA, Small Interfering [CS], Small Interfering RNA [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N219947-001	REDEMPLO	PLOZASIRAN SODIUM	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2025-11-18

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219947-001	10294474	2037-03-07	U-4360	Drug substance, Drug product	2025-12-17
N219947-001	11174481	2037-03-07		Drug substance, Drug product	2025-12-17
N219947-001	10597657	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17
N219947-001	11214801	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17
N219947-001	12365899	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219947-001	ODE-541	2032-11-18

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N219947-001	REDEMPLO	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-11-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219947-001	REDEMPLO	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219947-001	REDEMPLO	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219947-001	REDEMPLO	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-11-18	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219947-001	REDEMPLO	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-11-18	`a50c72e98297…`

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
2026-09-14 22:38:34	2026-08	N219947-001	10294474	2037-03-07	U-4360	Drug substance, Drug product	2025-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219947-001	11174481	2037-03-07		Drug substance, Drug product	2025-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219947-001	10597657	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219947-001	11214801	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219947-001	12365899	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219947-001	10294474	2037-03-07	U-4360	Drug substance, Drug product	2025-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219947-001	11174481	2037-03-07		Drug substance, Drug product	2025-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219947-001	10597657	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219947-001	11214801	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219947-001	12365899	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219947-001	10294474	2037-03-07	U-4360	Drug substance, Drug product	2025-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219947-001	11174481	2037-03-07		Drug substance, Drug product	2025-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219947-001	10597657	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219947-001	11214801	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219947-001	12365899	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219947-001	10294474	2037-03-07	U-4360	Drug substance, Drug product	2025-12-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219947-001	11174481	2037-03-07		Drug substance, Drug product	2025-12-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219947-001	10597657	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219947-001	11214801	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219947-001	12365899	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N219947-001	ODE-541	2032-11-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219947-001	ODE-541	2032-11-18	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219947-001	ODE-541	2032-11-18	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PLOZASIRAN	25 mg/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
XG9ARL6P25	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2728183	Internal RxNorm lookup
2728184	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
7fd37993-f85a-4af1-8bbe-133299f226ed	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84141-025-01	REDEMPLO	1 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	1		3
84141-025-01	REDEMPLO	1 in 1 CARTON	INJECTION, SOLUTION	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
84141-025-01	ML - Milliliter	84141-025	847d7c02-4cd1-4fb9-96ca-e2df9d4341a4	1	2025-12-16

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
REDEMPLO	PLOZASIRAN	Arrowhead Pharmaceuticals, Inc.	7fd37993-f85a-4af1-8bbe-133299f226ed	2026-08-25	Adverse reactions	Exact identifier application applno (NDA): 219947 application number: NDA219947 ndc (product): 84141-025

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2728183	plozasiran 25 MG in 0.5 ML Prefilled Syringe	PSN	7fd37993-f85a-4af1-8bbe-133299f226ed	3
2728184	Redemplo 25 MG in 0.5 ML Prefilled Syringe	PSN	7fd37993-f85a-4af1-8bbe-133299f226ed	3
2728184	0.5 ML plozasiran 50 MG/ML Prefilled Syringe [Redemplo]	SBD	7fd37993-f85a-4af1-8bbe-133299f226ed	3
2728183	0.5 ML plozasiran 50 MG/ML Prefilled Syringe	SCD	7fd37993-f85a-4af1-8bbe-133299f226ed	3
2728183	plozasiran (as plozasiran sodium) 25 MG per 0.5 ML Prefilled Syringe	SY	7fd37993-f85a-4af1-8bbe-133299f226ed	3
2728183	plozasiran 50 MG/ML per 0.5 ML Prefilled Syringe	SY	7fd37993-f85a-4af1-8bbe-133299f226ed	3
2728184	Redemplo 25 MG per 0.5 ML Prefilled Syringe	SY	7fd37993-f85a-4af1-8bbe-133299f226ed	3
2728184	Redemplo 50 MG/ML per 0.5 ML Prefilled Syringe	SY	7fd37993-f85a-4af1-8bbe-133299f226ed	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
84141-025-01	84141002501	1 SYRINGE, GLASS in 1 CARTON (84141-025-01) / 1 mL in 1 SYRINGE, GLASS	2025-11-19	No	No	Current