Sunlenca

Product NDC: 61958-3005
Requested package NDC: 61958-3005-1
11-digit product format: 619583005
Labeler code: 61958
Product ID: 61958-3005_142b440e-6eae-4d76-8312-b094de1380c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LENACAPAVIR SODIUM
Dosage form: KIT
Labeler: Gilead Sciences, Inc.
Application: NDA215973
Marketing category: NDA
Marketing start: 2025-03-18
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 · 5 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
2025-04-01 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…`

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
N215973-001	SUNLENCA	LENACAPAVIR SODIUM	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2022-12-22

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215973-001	9951043	2034-02-28	U-3507	Drug substance, Drug product	2023-01-18
N215973-001	10071985	2037-08-17		Drug substance, Drug product	2023-01-18
N215973-001	10654827	2037-08-17	U-3507		2023-01-18
N215973-001	11267799	2038-08-16		Drug substance	2023-01-18
N215973-001	12594267	2039-07-15		Drug product	2026-04-21
N215973-001	11944611	2041-08-28	U-3507		2024-04-23

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215973-001	NCE	2027-12-22

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	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215973-001	SUNLENCA	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-12-22	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 120 observed states.

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	N215973-001	9951043	2034-02-28	U-3507	Drug substance, Drug product	2023-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215973-001	10071985	2037-08-17		Drug substance, Drug product	2023-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215973-001	10654827	2037-08-17	U-3507		2023-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215973-001	11267799	2038-08-16		Drug substance	2023-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215973-001	12594267	2039-07-15		Drug product	2026-04-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215973-001	11944611	2041-08-28	U-3507		2024-04-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215973-001	9951043	2034-02-28	U-3507	Drug substance, Drug product	2023-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215973-001	10071985	2037-08-17		Drug substance, Drug product	2023-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215973-001	10654827	2037-08-17	U-3507		2023-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215973-001	11267799	2038-08-16		Drug substance	2023-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215973-001	12594267	2039-07-15		Drug product	2026-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215973-001	11944611	2041-08-28	U-3507		2024-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215973-001	9951043	2034-02-28	U-3507	Drug substance, Drug product	2023-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215973-001	10071985	2037-08-17		Drug substance, Drug product	2023-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215973-001	10654827	2037-08-17	U-3507		2023-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215973-001	11267799	2038-08-16		Drug substance	2023-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215973-001	11944611	2041-08-28	U-3507		2024-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215973-001	9951043	2034-02-28	U-3507	Drug substance, Drug product	2023-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215973-001	10071985	2037-08-17		Drug substance, Drug product	2023-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215973-001	10654827	2037-08-17	U-3507		2023-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215973-001	11267799	2038-08-16		Drug substance	2023-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215973-001	11944611	2041-08-28	U-3507		2024-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215973-001	9951043	2034-02-28	U-3507	Drug substance, Drug product	2023-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215973-001	10071985	2037-08-17		Drug substance, Drug product	2023-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215973-001	10654827	2037-08-17	U-3507		2023-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215973-001	11267799	2038-08-16		Drug substance	2023-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215973-001	11944611	2041-08-28	U-3507		2024-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215973-001	9951043	2034-02-28	U-3507	Drug substance, Drug product	2023-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215973-001	10071985	2037-08-17		Drug substance, Drug product	2023-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215973-001	10654827	2037-08-17	U-3507		2023-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215973-001	11267799	2038-08-16		Drug substance	2023-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215973-001	11944611	2041-08-28	U-3507		2024-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215973-001	9951043	2034-02-28	U-3507	Drug substance, Drug product	2023-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215973-001	10071985	2037-08-17		Drug substance, Drug product	2023-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215973-001	10654827	2037-08-17	U-3507		2023-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215973-001	11267799	2038-08-16		Drug substance	2023-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215973-001	11944611	2041-08-28	U-3507		2024-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215973-001	9951043	2034-02-28	U-3507	Drug substance, Drug product	2023-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215973-001	10071985	2037-08-17		Drug substance, Drug product	2023-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215973-001	10654827	2037-08-17	U-3507		2023-01-18	`03ed91905a0d…`

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	N215973-001	NCE	2027-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215973-001	NCE	2027-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215973-001	NCE	2027-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215973-001	NCE	2027-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215973-001	NCE	2027-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215973-001	NCE	2027-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215973-001	NCE	2027-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215973-001	NCE	2027-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215973-001	NCE	2027-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215973-001	NCE	2027-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215973-001	NCE	2027-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215973-001	NCE	2027-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215973-001	NCE	2027-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215973-001	NCE	2027-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215973-001	NCE	2027-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215973-001	NCE	2027-12-22	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215973-001	NCE	2027-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215973-001	NCE	2027-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215973-001	NCE	2027-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215973-001	NCE	2027-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215973-001	NCE	2027-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215973-001	NCE	2027-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215973-001	NCE	2027-12-22	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215973-001	NCE	2027-12-22	`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: Sunlenca
Listing expiration: 2027-12-31

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BDT58WJ9WE	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2625890	Internal RxNorm lookup
2625896	Internal RxNorm lookup
2625897	Internal RxNorm lookup
2625898	Internal RxNorm lookup
2625899	Internal RxNorm lookup
2625900	Internal RxNorm lookup
2625904	Internal RxNorm lookup
2625909	Internal RxNorm lookup
2625911	Internal RxNorm lookup
2625912	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
e5652804-29c4-40d7-aeb2-0142ed2a7b5b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a124dbe4-d4b1-4641-ba1c-c35ad0d241f9	Product name	1	20230919

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61958-3005-1	Sunlenca	1 in 1 CARTON	KIT	1		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61958-3005-1	ML - Milliliter	61958-3005	240997e1-bd23-4c9b-af65-1aa0c69dc80e	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61958-3005	SUNLENCA (LENACAPAVIR SODIUM) TABLET, FILM COATED SUNLENCA (LENACAPAVIR SODIUM) KIT [GILEAD SCIENCES, INC.]	7	Current NDC, 1 package rows	20250406_e5652804-29c4-40d7-aeb2-0142ed2a7b5b.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
Sunlenca	LENACAPAVIR SODIUM	Gilead Sciences, Inc.	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215973 application number: NDA215973 ndc (package): 61958-3005-1 ndc (product): 61958-3005 ndc11 (package): 61958300501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2625912	{2 (1.5 ML lenacapavir 309 MG/ML Injection [Sunlenca]) } Pack [Sunlenca 927 MG Kit]	BPCK	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625898	{4 (lenacapavir 300 MG Oral Tablet [Sunlenca]) } Pack [Sunlenca 4-Tablet Pack]	BPCK	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625900	{5 (lenacapavir 300 MG Oral Tablet [Sunlenca]) } Pack [Sunlenca 5-Tablet Pack]	BPCK	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625911	{2 (1.5 ML lenacapavir 309 MG/ML Injection) } Pack	GPCK	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625897	{4 (lenacapavir 300 MG Oral Tablet) } Pack	GPCK	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625899	{5 (lenacapavir 300 MG Oral Tablet) } Pack	GPCK	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625897	lenacapavir 300 MG 4-Tablet Pack	PSN	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625899	lenacapavir 300 MG 5-Tablet Pack	PSN	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625890	lenacapavir 300 MG Oral Tablet	PSN	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625904	lenacapavir 463.5 MG in 1.5 ML Injection	PSN	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625911	lenacapavir 927 MG 2-Vial Kit	PSN	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625896	Sunlenca 300 MG Oral Tablet	PSN	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625898	Sunlenca 4-Tablet Pack	PSN	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625909	Sunlenca 463.5 MG in 1.5 ML Injection	PSN	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625900	Sunlenca 5-Tablet Pack	PSN	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625912	Sunlenca 927 MG 2-Vial Kit	PSN	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625909	1.5 ML lenacapavir 309 MG/ML Injection [Sunlenca]	SBD	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625896	lenacapavir 300 MG Oral Tablet [Sunlenca]	SBD	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625904	1.5 ML lenacapavir 309 MG/ML Injection	SCD	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625890	lenacapavir 300 MG Oral Tablet	SCD	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625909	1.5 ML Sunlenca 309 MG/ML Injection	SY	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625890	lenacapavir 300 MG (as lenacapavir sodium 306.8 MG) Oral Tablet	SY	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625897	lenacapavir 300 MG 4-Tablet Pack	SY	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625899	lenacapavir 300 MG 5-Tablet Pack	SY	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625904	lenacapavir 463.5 MG per 1.5 ML Injection	SY	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625911	lenacapavir 927 MG 2-Vial Kit	SY	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625896	Sunlenca 300 MG Oral Tablet	SY	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625898	Sunlenca 4-Tablet Pack	SY	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625909	Sunlenca 463.5 MG per 1.5 ML Injection	SY	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625900	Sunlenca 5-Tablet Pack	SY	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12
2625912	Sunlenca 927 MG 2-Vial Kit	SY	e5652804-29c4-40d7-aeb2-0142ed2a7b5b	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
61958-3005-1	61958300501	1 KIT in 1 CARTON (61958-3005-1) * 1.5 mL in 1 VIAL (61958-3004-1)	1 kit	2025-03-18	No	No	Current