Home NDC 64764-800-28 Livtencity
Product NDC 64764-800
Requested package NDC 64764-800-28
11-digit product format 647640800
Labeler code 64764
Product ID 64764-800_14acb19d-0258-47df-a01a-bdca1ea05e54
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MARIBAVIR
Dosage form TABLET, COATED
Route ORAL
Labeler Takeda Pharmaceuticals America, Inc.
Application NDA215596
Marketing category NDA
Marketing start 2021-11-23
Substance MARIBAVIR
Active strength 200 mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Cytomegalovirus pUL97 Kinase Inhibitor [EPC], Cytomegalovirus pUL97 Kinase Inhibitors [MoA], 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 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 N215596-001 LIVTENCITY MARIBAVIR 200MG TABLET / ORAL RLD, RS 2021-11-23
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215596-001 12447169 2031-10-27 U-4329 2025-11-18 N215596-001 12661368 2031-10-27 U-4572 2026-07-14 N215596-001 11684632 2032-01-04 U-3650 2023-07-21 N215596-001 12213989 2042-11-18 U-4137 2025-02-27 N215596-001 12433907 2042-11-18 U-4289 2025-10-28 N215596-001 12447170 2042-11-18 U-4328 2025-11-18 N215596-001 12295940 2043-10-11 Drug substance, Drug product 2025-05-29 N215596-001 12527771 2043-10-11 Drug substance, Drug product 2026-02-12
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215596-001 NCE 2026-11-23 N215596-001 ODE-388 2028-11-23
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 2026-09-14 22:38:34 2026-08 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215596-001 LIVTENCITY 200MG TABLET / ORAL RLD, RS 2021-11-23 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 55 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 N215596-001 12447169 2031-10-27 U-4329 2025-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215596-001 12661368 2031-10-27 U-4572 2026-07-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215596-001 11684632 2032-01-04 U-3650 2023-07-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215596-001 12213989 2042-11-18 U-4137 2025-02-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215596-001 12433907 2042-11-18 U-4289 2025-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215596-001 12447170 2042-11-18 U-4328 2025-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215596-001 12295940 2043-10-11 Drug substance, Drug product 2025-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215596-001 12527771 2043-10-11 Drug substance, Drug product 2026-02-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215596-001 12447169 2031-10-27 U-4329 2025-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215596-001 12661368 2031-10-27 U-4572 2026-07-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215596-001 11684632 2032-01-04 U-3650 2023-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215596-001 12213989 2042-11-18 U-4137 2025-02-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215596-001 12433907 2042-11-18 U-4289 2025-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215596-001 12447170 2042-11-18 U-4328 2025-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215596-001 12295940 2043-10-11 Drug substance, Drug product 2025-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215596-001 12527771 2043-10-11 Drug substance, Drug product 2026-02-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215596-001 12447169 2031-10-27 U-4329 2025-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215596-001 11684632 2032-01-04 U-3650 2023-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215596-001 12213989 2042-11-18 U-4137 2025-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215596-001 12433907 2042-11-18 U-4289 2025-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215596-001 12447170 2042-11-18 U-4328 2025-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215596-001 12295940 2043-10-11 Drug substance, Drug product 2025-05-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215596-001 12447169 2031-10-27 U-4329 2025-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215596-001 11684632 2032-01-04 U-3650 2023-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215596-001 12213989 2042-11-18 U-4137 2025-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215596-001 12433907 2042-11-18 U-4289 2025-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215596-001 12447170 2042-11-18 U-4328 2025-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215596-001 12295940 2043-10-11 Drug substance, Drug product 2025-05-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215596-001 11684632 2032-01-04 U-3650 2023-07-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215596-001 12213989 2042-11-18 U-4137 2025-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215596-001 12295940 2043-10-11 Drug substance, Drug product 2025-05-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215596-001 11684632 2032-01-04 U-3650 2023-07-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215596-001 12213989 2042-11-18 U-4137 2025-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215596-001 11684632 2032-01-04 U-3650 2023-07-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215596-001 11684632 2032-01-04 U-3650 2023-07-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215596-001 11684632 2032-01-04 U-3650 2023-07-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215596-001 11684632 2032-01-04 U-3650 2023-07-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215596-001 11684632 2032-01-04 U-3650 2023-07-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215596-001 11684632 2032-01-04 U-3650 2023-07-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215596-001 11684632 2032-01-04 U-3650 2023-07-21 79d66fd596c7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 59 observed states.
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 Livtencity
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MARIBAVIR 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PTB4X93HE1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2586073 Internal RxNorm lookup 2586079 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 64764-800-28 Livtencity 28 in 1 BOTTLE TABLET, COATED 28 14 64764-800-28 Livtencity 1 in 1 CARTON TABLET, COATED 1 14 64764-800-56 Livtencity 56 in 1 BOTTLE TABLET, COATED 56 14 64764-800-56 Livtencity 1 in 1 CARTON TABLET, COATED 1 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64764-800 LIVTENCITY (MARIBAVIR) TABLET, COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] 11 Current NDC, Legacy NDC, 4 package rows 20250309_c94fc2c5-e840-4f18-b7d8-d5eacb26d3a0.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 64764-800-28 64764080028 1 BOTTLE in 1 CARTON (64764-800-28) / 28 TABLET, COATED in 1 BOTTLE 1 bottle 2021-11-23 0000-00-00 No No Current