Home NDC 61958-3001 Sunlenca
Product NDC 61958-3001
11-digit product format 619583001
Labeler code 61958
Product ID 61958-3001_12f3f90c-8b72-4e1f-875e-6fcaf4b15959
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LENACAPAVIR SODIUM
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Gilead Sciences, Inc.
Application NDA215974
Marketing category NDA
Marketing start 2022-12-22
Substance LENACAPAVIR SODIUM
Active strength 300 mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Capsid Inhibitors [MoA], Human Immunodeficiency Virus 1 Capsid Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA]
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 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 N215974-001 SUNLENCA LENACAPAVIR SODIUM EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22
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 N215974-001 9951043 2034-02-28 U-3507 Drug substance, Drug product 2023-01-18 N215974-001 10071985 2037-08-17 Drug substance, Drug product 2023-01-18 N215974-001 10654827 2037-08-17 U-3507 2023-01-18 N215974-001 11267799 2038-08-16 Drug substance 2023-01-18 N215974-001 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 N215974-001 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 Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215974-001 SUNLENCA EQ 300MG BASE TABLET / ORAL RLD, RS 2022-12-22 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 107 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 N215974-001 9951043 2034-02-28 U-3507 Drug substance, Drug product 2023-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215974-001 10071985 2037-08-17 Drug substance, Drug product 2023-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215974-001 10654827 2037-08-17 U-3507 2023-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215974-001 11267799 2038-08-16 Drug substance 2023-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215974-001 11944611 2041-08-28 U-3507 2024-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215974-001 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 N215974-001 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 N215974-001 10654827 2037-08-17 U-3507 2023-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215974-001 11267799 2038-08-16 Drug substance 2023-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215974-001 11944611 2041-08-28 U-3507 2024-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215974-001 9951043 2034-02-28 U-3507 Drug substance, Drug product 2023-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215974-001 10071985 2037-08-17 Drug substance, Drug product 2023-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215974-001 10654827 2037-08-17 U-3507 2023-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215974-001 11267799 2038-08-16 Drug substance 2023-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215974-001 11944611 2041-08-28 U-3507 2024-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215974-001 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 N215974-001 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 N215974-001 10654827 2037-08-17 U-3507 2023-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215974-001 11267799 2038-08-16 Drug substance 2023-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215974-001 11944611 2041-08-28 U-3507 2024-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215974-001 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 N215974-001 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 N215974-001 10654827 2037-08-17 U-3507 2023-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215974-001 11267799 2038-08-16 Drug substance 2023-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215974-001 11944611 2041-08-28 U-3507 2024-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215974-001 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 N215974-001 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 N215974-001 10654827 2037-08-17 U-3507 2023-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215974-001 11267799 2038-08-16 Drug substance 2023-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215974-001 11944611 2041-08-28 U-3507 2024-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215974-001 9951043 2034-02-28 U-3507 Drug substance, Drug product 2023-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215974-001 10071985 2037-08-17 Drug substance, Drug product 2023-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215974-001 10654827 2037-08-17 U-3507 2023-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215974-001 11267799 2038-08-16 Drug substance 2023-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215974-001 11944611 2041-06-04 U-3507 Drug substance, Drug product 2024-04-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215974-001 9951043 2034-02-28 U-3507 Drug substance, Drug product 2023-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215974-001 10071985 2037-08-17 Drug substance, Drug product 2023-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215974-001 10654827 2037-08-17 U-3507 2023-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215974-001 11267799 2038-08-16 Drug substance 2023-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215974-001 11944611 2041-06-04 U-3507 Drug substance, Drug product 2024-04-23 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Sunlenca
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LENACAPAVIR SODIUM 300 mg/1
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61958-3001-1 Sunlenca 1 in 1 CARTON TABLET, FILM COATED 1 12 61958-3001-1 Sunlenca 1 in 1 POUCH TABLET, FILM COATED 1 12 61958-3001-2 Sunlenca 1 in 1 POUCH TABLET, FILM COATED 1 12 61958-3001-2 Sunlenca 1 in 1 CARTON TABLET, FILM COATED 1 12 61958-3001-3 Sunlenca 4 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 4 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61958-3001 SUNLENCA (LENACAPAVIR SODIUM) TABLET, FILM COATED SUNLENCA (LENACAPAVIR SODIUM) KIT [GILEAD SCIENCES, INC.] 7 Current NDC, Legacy NDC, 5 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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61958-3001-1 61958300101 1 POUCH in 1 CARTON (61958-3001-1) / 1 BLISTER PACK in 1 POUCH / 4 TABLET, FILM COATED in 1 BLISTER PACK 1 pouch 2022-12-22 0000-00-00 No No Current 61958-3001-2 61958300102 1 POUCH in 1 CARTON (61958-3001-2) / 1 BLISTER PACK in 1 POUCH / 5 TABLET, FILM COATED in 1 BLISTER PACK 1 pouch 2022-12-22 0000-00-00 No No Current 61958-3001-3 61958300103 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3001-3) 2024-11-13 No No Current