Home NDC 61958-2501 Biktarvy
Product NDC 61958-2501
11-digit product format 619582501
Labeler code 61958
Product ID 61958-2501_245103e5-132e-4695-9b7d-bda2f2830ec3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
Dosage form TABLET
Route ORAL
Labeler Gilead Sciences, Inc.
Application NDA210251
Marketing category NDA
Marketing start 2018-02-07
Substance BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Active strength 50; 200; 25 mg/1; mg/1; mg/1
Pharmacologic classes Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210251-001 BIKTARVY BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE EQ 50MG BASE;200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2018-02-07 N210251-002 BIKTARVY BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE EQ 30MG BASE;120MG;EQ 15MG BASE TABLET / ORAL RLD 2021-10-07
Orange Book patents# Current patent rows page 1 of 1 · 20 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210251-001 8754065 2032-08-15 U-257 Drug substance, Drug product 2018-02-26 N210251-001 9296769 2032-08-15 U-257 Drug substance, Drug product 2018-02-26 N210251-001 8754065*PED 2033-02-15 Pediatric extension N210251-001 9296769*PED 2033-02-15 Pediatric extension N210251-001 9216996 2033-12-19 Drug substance, Drug product 2018-02-26 N210251-001 9732092 2033-12-19 Drug substance, Drug product 2018-02-26 N210251-001 10385067 2035-06-19 U-257 2019-08-30 N210251-001 9708342 2035-06-19 Drug substance, Drug product 2018-02-26 N210251-001 10548846 2036-11-08 Drug product 2020-02-28 N210251-001 11744802 2036-11-08 Drug product 2023-10-04 N210251-001 12594244 2036-11-08 U-257 Drug product 2026-04-30 N210251-002 8754065 2032-08-15 U-257 Drug substance, Drug product 2021-10-28 N210251-002 9296769 2032-08-15 U-257 Drug substance, Drug product 2021-10-28 N210251-002 8754065*PED 2033-02-15 Pediatric extension N210251-002 9296769*PED 2033-02-15 Pediatric extension N210251-002 9216996 2033-12-19 Drug substance, Drug product 2021-10-28 N210251-002 9732092 2033-12-19 Drug substance, Drug product 2021-10-28 N210251-002 10385067 2035-06-19 U-257 2021-10-28 N210251-002 9708342 2035-06-19 Drug substance, Drug product 2021-10-28 N210251-002 12594244 2036-11-08 U-257 Drug product 2026-04-30
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 9 matching rows.
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 · 74 observed 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 N210251-001 BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2018-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210251-002 BIKTARVY EQ 30MG BASE;120MG;EQ 15MG BASE TABLET / ORAL RLD 2021-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-001 BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2018-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-002 BIKTARVY EQ 30MG BASE;120MG;EQ 15MG BASE TABLET / ORAL RLD 2021-10-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210251-001 BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2018-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210251-002 BIKTARVY EQ 30MG BASE;120MG;EQ 15MG BASE TABLET / ORAL RLD 2021-10-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210251-001 BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2018-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210251-002 BIKTARVY EQ 30MG BASE;120MG;EQ 15MG BASE TABLET / ORAL RLD 2021-10-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210251-001 BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2018-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210251-002 BIKTARVY EQ 30MG BASE;120MG;EQ 15MG BASE TABLET / ORAL RLD 2021-10-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210251-001 BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2018-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210251-002 BIKTARVY EQ 30MG BASE;120MG;EQ 15MG BASE TABLET / ORAL RLD 2021-10-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210251-001 BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2018-02-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210251-002 BIKTARVY EQ 30MG BASE;120MG;EQ 15MG BASE TABLET / ORAL RLD 2021-10-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210251-001 BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2018-02-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210251-002 BIKTARVY EQ 30MG BASE;120MG;EQ 15MG BASE TABLET / ORAL RLD 2021-10-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210251-001 BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2018-02-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210251-002 BIKTARVY EQ 30MG BASE;120MG;EQ 15MG BASE TABLET / ORAL RLD 2021-10-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210251-001 BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2018-02-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210251-002 BIKTARVY EQ 30MG BASE;120MG;EQ 15MG BASE TABLET / ORAL RLD 2021-10-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210251-001 BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2018-02-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210251-002 BIKTARVY EQ 30MG BASE;120MG;EQ 15MG BASE TABLET / ORAL RLD 2021-10-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210251-001 BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2018-02-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210251-002 BIKTARVY EQ 30MG BASE;120MG;EQ 15MG BASE TABLET / ORAL RLD 2021-10-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210251-001 BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2018-02-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210251-002 BIKTARVY EQ 30MG BASE;120MG;EQ 15MG BASE TABLET / ORAL RLD 2021-10-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210251-001 BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2018-02-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N210251-002 BIKTARVY EQ 30MG BASE;120MG;EQ 15MG BASE TABLET / ORAL RLD 2021-10-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210251-001 BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2018-02-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210251-002 BIKTARVY EQ 30MG BASE;120MG;EQ 15MG BASE TABLET / ORAL RLD 2021-10-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210251-001 BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2018-02-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N210251-002 BIKTARVY EQ 30MG BASE;120MG;EQ 15MG BASE TABLET / ORAL RLD 2021-10-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210251-001 BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2018-02-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N210251-002 BIKTARVY EQ 30MG BASE;120MG;EQ 15MG BASE TABLET / ORAL RLD 2021-10-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210251-001 BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2018-02-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210251-001 BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2018-02-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N210251-002 BIKTARVY EQ 30MG BASE;120MG;EQ 15MG BASE TABLET / ORAL RLD 2021-10-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210251-001 BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2018-02-07 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N210251-002 BIKTARVY EQ 30MG BASE;120MG;EQ 15MG BASE TABLET / ORAL RLD 2021-10-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210251-001 BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE TABLET / ORAL RLD, RS 2018-02-07 87673890dc5c…
Observed Orange Book patent history# Patent history page 1 of 19 · 755 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 N210251-001 8754065 2032-08-15 U-257 Drug substance, Drug product 2018-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210251-001 9296769 2032-08-15 U-257 Drug substance, Drug product 2018-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210251-001 8754065*PED 2033-02-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210251-001 9296769*PED 2033-02-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210251-001 9216996 2033-12-19 Drug substance, Drug product 2018-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210251-001 9732092 2033-12-19 Drug substance, Drug product 2018-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210251-001 10385067 2035-06-19 U-257 2019-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210251-001 9708342 2035-06-19 Drug substance, Drug product 2018-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210251-001 10548846 2036-11-08 Drug product 2020-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210251-001 11744802 2036-11-08 Drug product 2023-10-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210251-002 8754065 2032-08-15 U-257 Drug substance, Drug product 2021-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210251-002 9296769 2032-08-15 U-257 Drug substance, Drug product 2021-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210251-002 8754065*PED 2033-02-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210251-002 9296769*PED 2033-02-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210251-002 9216996 2033-12-19 Drug substance, Drug product 2021-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210251-002 9732092 2033-12-19 Drug substance, Drug product 2021-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210251-002 10385067 2035-06-19 U-257 2021-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210251-002 9708342 2035-06-19 Drug substance, Drug product 2021-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-001 7390791 2025-01-07 Drug substance, Drug product 2018-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-001 7390791*PED 2025-07-07 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-001 8754065 2032-08-15 U-257 Drug substance, Drug product 2018-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-001 9296769 2032-08-15 U-257 Drug substance, Drug product 2018-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-001 8754065*PED 2033-02-15 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-001 9296769*PED 2033-02-15 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-001 9216996 2033-12-19 Drug substance, Drug product 2018-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-001 9732092 2033-12-19 Drug substance, Drug product 2018-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-001 10385067 2035-06-19 U-257 2019-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-001 9708342 2035-06-19 Drug substance, Drug product 2018-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-001 10548846 2036-11-08 Drug product 2020-02-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-001 11744802 2036-11-08 Drug product 2023-10-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-002 7390791 2025-01-07 Drug substance, Drug product 2021-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-002 7390791*PED 2025-07-07 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-002 8754065 2032-08-15 U-257 Drug substance, Drug product 2021-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-002 9296769 2032-08-15 U-257 Drug substance, Drug product 2021-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-002 8754065*PED 2033-02-15 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-002 9296769*PED 2033-02-15 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-002 9216996 2033-12-19 Drug substance, Drug product 2021-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-002 9732092 2033-12-19 Drug substance, Drug product 2021-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-002 10385067 2035-06-19 U-257 2021-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210251-002 9708342 2035-06-19 Drug substance, Drug product 2021-10-28 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 6 · 233 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Biktarvy
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BICTEGRAVIR SODIUM 50 mg/1 EMTRICITABINE 200 mg/1 TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4L5MP1Y7W7 Internal UNII lookup FWF6Q91TZO Internal UNII lookup G70B4ETF4S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1999667 Internal RxNorm lookup 1999673 Internal RxNorm lookup 2584354 Internal RxNorm lookup 2584356 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 61958-2501-1 These highlights do not include all the information needed to use BIKTARVY safely and effectively. See full prescribing information for BIKTARVY. BIKTARVY ® (bictegravir, emtricitabine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2018 61958-2501-1 These highlights do not include all the information needed to use BIKTARVY safely and effectively. See full prescribing information for BIKTARVY. BIKTARVY ® (bictegravir, emtricitabine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2018 61958-2501-1 These highlights do not include all the information needed to use BIKTARVY safely and effectively. See full prescribing information for BIKTARVY. BIKTARVY ® (bictegravir, emtricitabine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2018 61958-2501-2 These highlights do not include all the information needed to use BIKTARVY safely and effectively. See full prescribing information for BIKTARVY. BIKTARVY ® (bictegravir, emtricitabine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2018 61958-2501-2 These highlights do not include all the information needed to use BIKTARVY safely and effectively. See full prescribing information for BIKTARVY. BIKTARVY ® (bictegravir, emtricitabine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2018 61958-2501-2 These highlights do not include all the information needed to use BIKTARVY safely and effectively. See full prescribing information for BIKTARVY. BIKTARVY ® (bictegravir, emtricitabine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2018
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61958-2501-1 Biktarvy 30 in 1 BOTTLE, PLASTIC TABLET 30 24 61958-2501-2 Biktarvy 7 in 1 BOTTLE, PLASTIC TABLET 7 24 61958-2501-3 Biktarvy 30 in 1 BLISTER PACK TABLET 30 24 61958-2501-5 Biktarvy 30 in 1 BLISTER PACK TABLET 30 24
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61958-2501 BIKTARVY (BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.] 20 Current NDC, Legacy NDC, 4 package rows 20241024_664cb8f0-1f65-441b-b0d9-ba3d798be309.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 · 2 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Biktarvy BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE Gilead Sciences, Inc. 664cb8f0-1f65-441b-b0d9-ba3d798be309 2026-07-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 210251 application number: NDA210251 ndc (product): 61958-2501 Biktarvy BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE A-S Medication Solutions 0476d7eb-1024-4821-bbe7-abaacfda32a2 2024-04-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 210251 application number: NDA210251
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 61958-2501-1 61958250101 30 TABLET in 1 BOTTLE, PLASTIC (61958-2501-1) 30 tablet 2018-02-07 0000-00-00 No No Current 61958-2501-2 61958250102 7 TABLET in 1 BOTTLE, PLASTIC (61958-2501-2) 7 tablet 2018-07-26 0000-00-00 No No Current 61958-2501-3 61958250103 30 TABLET in 1 BLISTER PACK (61958-2501-3) 30 tablet 2021-08-24 0000-00-00 No No Current 61958-2501-5 61958250105 30 TABLET in 1 BLISTER PACK (61958-2501-5) 30 tablet 2026-03-30 No No Current