DAWNZERA

Product NDC: 71860-103
11-digit product format: 718600103
Labeler code: 71860
Product ID: 71860-103_3f909bfc-3281-a444-e063-6294a90a221f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: donidalorsen
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Ionis Pharmaceuticals Inc.
Application: NDA219407
Marketing category: NDA
Marketing start: 2025-08-21
Substance: DONIDALORSEN SODIUM
Active strength: 80 mg/.8mL
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 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
N219407-001	DAWNZERA (AUTOINJECTOR)	DONIDALORSEN SODIUM	EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2025-08-21

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
N219407-001	9315811	2032-10-21	U-3010		2025-09-16
N219407-001	9127276	2034-05-01		Drug substance	2025-09-16
N219407-001	9181549	2034-05-01		Drug substance	2025-09-16
N219407-001	9670492	2034-08-28		Drug substance	2025-09-16
N219407-001	10294477	2035-05-01	U-3010	Drug substance, Drug product	2025-09-16

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219407-001	ODE-550	2032-08-21

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	N219407-001	DAWNZERA (AUTOINJECTOR)	EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-08-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219407-001	DAWNZERA (AUTOINJECTOR)	EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-08-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219407-001	DAWNZERA (AUTOINJECTOR)	EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219407-001	DAWNZERA (AUTOINJECTOR)	EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-08-21	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219407-001	DAWNZERA (AUTOINJECTOR)	EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-08-21	`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	N219407-001	9315811	2032-10-21	U-3010		2025-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219407-001	9127276	2034-05-01		Drug substance	2025-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219407-001	9181549	2034-05-01		Drug substance	2025-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219407-001	9670492	2034-08-28		Drug substance	2025-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219407-001	10294477	2035-05-01	U-3010	Drug substance, Drug product	2025-09-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219407-001	9315811	2032-10-21	U-3010		2025-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219407-001	9127276	2034-05-01		Drug substance	2025-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219407-001	9181549	2034-05-01		Drug substance	2025-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219407-001	9670492	2034-08-28		Drug substance	2025-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219407-001	10294477	2035-05-01	U-3010	Drug substance, Drug product	2025-09-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219407-001	9315811	2032-10-21	U-3010		2025-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219407-001	9127276	2034-05-01		Drug substance	2025-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219407-001	9181549	2034-05-01		Drug substance	2025-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219407-001	9670492	2034-08-28		Drug substance	2025-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219407-001	10294477	2035-05-01	U-3010	Drug substance, Drug product	2025-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219407-001	9315811	2032-10-21	U-3010		2025-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219407-001	9127276	2034-05-01		Drug substance	2025-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219407-001	9181549	2034-05-01		Drug substance	2025-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219407-001	9670492	2034-08-28		Drug substance	2025-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219407-001	10294477	2035-05-01	U-3010	Drug substance, Drug product	2025-09-16	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219407-001	9315811	2032-10-21	U-3010		2025-09-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219407-001	9127276	2034-05-01		Drug substance	2025-09-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219407-001	9181549	2034-05-01		Drug substance	2025-09-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219407-001	9670492	2034-08-28		Drug substance	2025-09-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219407-001	10294477	2035-05-01	U-3010	Drug substance, Drug product	2025-09-16	`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	N219407-001	ODE-550	2032-08-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219407-001	ODE-550	2032-08-21	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219407-001	ODE-550	2032-08-21	`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: DAWNZERA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DONIDALORSEN SODIUM	80 mg/.8mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Y30VEG5PH1	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2724447	Internal RxNorm lookup
2724453	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
3ff501e0-f75f-07da-e063-6294a90a0cb7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71860-103-01	DAWNZERA	1 in 1 CARTON	INJECTION, SOLUTION	1		1
71860-103-01	DAWNZERA	0.8 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	0.8		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71860-103-01	ML - Milliliter	71860-103	636ed397-5039-4f3f-bec3-4857ac0340f7	1	2025-10-14

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
DAWNZERA	DONIDALORSEN	Ionis Pharmaceuticals Inc.	3ff501e0-f75f-07da-e063-6294a90a0cb7	2025-09-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219407 application number: NDA219407 ndc (product): 71860-103

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2724453	DAWNZERA 80 MG in 0.8 ML Auto-Injector	PSN	3ff501e0-f75f-07da-e063-6294a90a0cb7	1
2724447	donidalorsen 80 MG in 0.8 ML Auto-Injector	PSN	3ff501e0-f75f-07da-e063-6294a90a0cb7	1
2724453	0.8 ML donidalorsen 100 MG/ML Auto-Injector [Dawnzera]	SBD	3ff501e0-f75f-07da-e063-6294a90a0cb7	1
2724447	0.8 ML donidalorsen 100 MG/ML Auto-Injector	SCD	3ff501e0-f75f-07da-e063-6294a90a0cb7	1
2724453	Dawnzera 80 MG (equivalent to donidalorsen sodium 84 MG) per 0.8 ML Auto-Injector	SY	3ff501e0-f75f-07da-e063-6294a90a0cb7	1
2724453	Dawnzera 80 MG per 0.8 ML Auto-Injector	SY	3ff501e0-f75f-07da-e063-6294a90a0cb7	1
2724447	donidalorsen 80 MG (equivalent to donidalorsen sodium 84 MG) per 0.8 ML Auto-Injector	SY	3ff501e0-f75f-07da-e063-6294a90a0cb7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71860-103-01	71860010301	1 SYRINGE, GLASS in 1 CARTON (71860-103-01) / .8 mL in 1 SYRINGE, GLASS	2025-08-21	No	No	Current