Home NDC 0006-5007 DELSTRIGO
Product NDC 0006-5007
11-digit product format 000065007
Labeler code 0006
Product ID 0006-5007_237e7245-b6e8-40df-8d66-4bb122136834
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name doravirine, lamivudine, and tenofovir disoproxil fumarate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Merck Sharp & Dohme LLC
Application NDA210807
Marketing category NDA
Marketing start 2018-07-20
Substance DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength 100; 300; 300 mg/1; mg/1; mg/1
Pharmacologic classes Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]
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 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 N210807-001 DELSTRIGO DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30
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 N210807-001 8486975 2032-08-30 U-2395 Drug substance, Drug product 2018-09-17 N210807-001 8486975 2032-08-30 U-2629 Drug substance, Drug product 2018-09-17 N210807-001 8486975 2032-08-30 U-3307 Drug substance, Drug product 2018-09-17 N210807-001 10603282 2036-11-29 Drug product 2020-04-17 N210807-001 10842751 2036-11-29 Drug product 2020-12-16
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 · 41 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 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210807-001 DELSTRIGO 100MG;300MG;300MG TABLET / ORAL RLD, RS 2018-08-30 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 5 · 183 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 N210807-001 8486975 2032-08-30 U-2629 Drug substance, Drug product 2018-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210807-001 8486975 2032-08-30 U-2395 Drug substance, Drug product 2018-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210807-001 8486975 2032-08-30 U-3307 Drug substance, Drug product 2018-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210807-001 10603282 2036-11-29 Drug product 2020-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210807-001 10842751 2036-11-29 Drug product 2020-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210807-001 8486975 2032-08-30 U-2629 Drug substance, Drug product 2018-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210807-001 8486975 2032-08-30 U-2395 Drug substance, Drug product 2018-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210807-001 8486975 2032-08-30 U-3307 Drug substance, Drug product 2018-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210807-001 10603282 2036-11-29 Drug product 2020-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210807-001 10842751 2036-11-29 Drug product 2020-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210807-001 8486975 2032-08-30 U-2629 Drug substance, Drug product 2018-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210807-001 8486975 2032-08-30 U-2395 Drug substance, Drug product 2018-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210807-001 8486975 2032-08-30 U-3307 Drug substance, Drug product 2018-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210807-001 10603282 2036-11-29 Drug product 2020-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210807-001 10842751 2036-11-29 Drug product 2020-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210807-001 8486975 2032-08-30 U-2629 Drug substance, Drug product 2018-09-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210807-001 8486975 2032-08-30 U-2395 Drug substance, Drug product 2018-09-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210807-001 8486975 2032-08-30 U-3307 Drug substance, Drug product 2018-09-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210807-001 10603282 2036-11-29 Drug product 2020-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210807-001 10842751 2036-11-29 Drug product 2020-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210807-001 8486975 2032-08-30 U-2629 Drug substance, Drug product 2018-09-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210807-001 8486975 2032-08-30 U-2395 Drug substance, Drug product 2018-09-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210807-001 8486975 2032-08-30 U-3307 Drug substance, Drug product 2018-09-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210807-001 10603282 2036-11-29 Drug product 2020-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210807-001 10842751 2036-11-29 Drug product 2020-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210807-001 8486975 2032-08-30 U-2629 Drug substance, Drug product 2018-09-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210807-001 8486975 2032-08-30 U-2395 Drug substance, Drug product 2018-09-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210807-001 8486975 2032-08-30 U-3307 Drug substance, Drug product 2018-09-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210807-001 10603282 2036-11-29 Drug product 2020-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210807-001 10842751 2036-11-29 Drug product 2020-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210807-001 8486975 2032-08-30 U-2629 Drug substance, Drug product 2018-09-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210807-001 8486975 2032-08-30 U-2395 Drug substance, Drug product 2018-09-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210807-001 8486975 2032-08-30 U-3307 Drug substance, Drug product 2018-09-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210807-001 10603282 2036-11-29 Drug product 2020-04-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210807-001 10842751 2036-11-29 Drug product 2020-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210807-001 8486975 2031-10-07 U-2629 Drug substance, Drug product 2018-09-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210807-001 8486975 2031-10-07 U-2395 Drug substance, Drug product 2018-09-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210807-001 8486975 2031-10-07 U-3307 Drug substance, Drug product 2018-09-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210807-001 10603282 2036-11-29 Drug product 2020-04-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210807-001 10842751 2036-11-29 Drug product 2020-12-16 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 67 observed states.
Additional Listing Data#
Finished product Yes
Brand name base DELSTRIGO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DORAVIRINE 100 mg/1 LAMIVUDINE 300 mg/1 TENOFOVIR DISOPROXIL FUMARATE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 913P6LK81M Internal UNII lookup 2T8Q726O95 Internal UNII lookup OTT9J7900I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2055813 Internal RxNorm lookup 2055815 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 0006-5007-01 DELSTRIGO 30 in 1 BOTTLE TABLET, FILM COATED 30 23
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0006-5007 DELSTRIGO (DORAVIRINE, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [MERCK SHARP & DOHME LLC] 20 Current NDC, Legacy NDC, 1 package rows 20250207_cd1e9f84-607a-46d3-b01e-2736018d67b6.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 DELSTRIGO DORAVIRINE, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE Merck Sharp & Dohme LLC cd1e9f84-607a-46d3-b01e-2736018d67b6 2026-07-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 210807 application number: NDA210807 ndc (product): 0006-5007
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0006-5007-01 00006500701 30 TABLET, FILM COATED in 1 BOTTLE (0006-5007-01) 2018-07-20 0000-00-00 No No Current