Home NDC 49884-770 Tolvaptan
Product NDC 49884-770
11-digit product format 498840770
Labeler code 49884
Product ID 49884-770_73a11064-c070-4323-bb7a-59dd36dc1eee
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tolvaptan
Dosage form TABLET
Route ORAL
Labeler Endo USA, Inc.
Application ANDA206119
Marketing category ANDA
Marketing start 2022-03-10
Substance TOLVAPTAN
Active strength 30 mg/1
Pharmacologic classes Vasopressin V2 Receptor Antagonist [EPC], Vasopressin V2 Receptor Antagonists [MoA]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206119-001 TOLVAPTAN TOLVAPTAN 15MG TABLET / ORAL AB1 2022-02-15 A206119-002 TOLVAPTAN TOLVAPTAN 30MG TABLET / ORAL AB1 2022-02-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 62 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 A206119-001 TOLVAPTAN 15MG TABLET / ORAL AB1 2022-02-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206119-002 TOLVAPTAN 30MG TABLET / ORAL AB1 2022-02-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206119-001 TOLVAPTAN 15MG TABLET / ORAL AB1 2022-02-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206119-002 TOLVAPTAN 30MG TABLET / ORAL AB1 2022-02-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206119-001 TOLVAPTAN 15MG TABLET / ORAL AB1 2022-02-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206119-002 TOLVAPTAN 30MG TABLET / ORAL AB1 2022-02-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206119-001 TOLVAPTAN 15MG TABLET / ORAL AB 2022-02-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206119-002 TOLVAPTAN 30MG TABLET / ORAL AB 2022-02-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206119-001 TOLVAPTAN 15MG TABLET / ORAL AB 2022-02-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206119-002 TOLVAPTAN 30MG TABLET / ORAL AB 2022-02-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206119-001 TOLVAPTAN 15MG TABLET / ORAL AB 2022-02-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206119-002 TOLVAPTAN 30MG TABLET / ORAL AB 2022-02-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206119-001 TOLVAPTAN 15MG TABLET / ORAL AB 2022-02-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206119-002 TOLVAPTAN 30MG TABLET / ORAL AB 2022-02-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206119-001 TOLVAPTAN 15MG TABLET / ORAL AB 2022-02-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206119-002 TOLVAPTAN 30MG TABLET / ORAL AB 2022-02-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206119-001 TOLVAPTAN 15MG TABLET / ORAL AB 2022-02-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206119-002 TOLVAPTAN 30MG TABLET / ORAL AB 2022-02-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206119-001 TOLVAPTAN 15MG TABLET / ORAL AB 2022-02-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206119-002 TOLVAPTAN 30MG TABLET / ORAL AB 2022-02-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206119-001 TOLVAPTAN 15MG TABLET / ORAL AB 2022-02-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206119-002 TOLVAPTAN 30MG TABLET / ORAL AB 2022-02-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206119-001 TOLVAPTAN 15MG TABLET / ORAL AB 2022-02-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206119-002 TOLVAPTAN 30MG TABLET / ORAL AB 2022-02-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206119-001 TOLVAPTAN 15MG TABLET / ORAL AB 2022-02-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206119-002 TOLVAPTAN 30MG TABLET / ORAL AB 2022-02-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206119-001 TOLVAPTAN 15MG TABLET / ORAL AB 2022-02-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206119-002 TOLVAPTAN 30MG TABLET / ORAL AB 2022-02-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206119-001 TOLVAPTAN 15MG TABLET / ORAL AB 2022-02-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206119-002 TOLVAPTAN 30MG TABLET / ORAL AB 2022-02-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206119-001 TOLVAPTAN 15MG TABLET / ORAL AB 2022-02-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206119-002 TOLVAPTAN 30MG TABLET / ORAL AB 2022-02-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206119-001 TOLVAPTAN 15MG TABLET / ORAL AB 2022-02-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206119-002 TOLVAPTAN 30MG TABLET / ORAL AB 2022-02-15 4b0b4de00fa7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206119-001 TOLVAPTAN 15MG TABLET / ORAL AB 2022-02-15 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206119-002 TOLVAPTAN 30MG TABLET / ORAL AB 2022-02-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206119-001 TOLVAPTAN 15MG TABLET / ORAL AB 2022-02-15 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A206119-002 TOLVAPTAN 30MG TABLET / ORAL AB 2022-02-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206119-001 TOLVAPTAN 15MG TABLET / ORAL AB 2022-02-15 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A206119-002 TOLVAPTAN 30MG TABLET / ORAL AB 2022-02-15 ea1830bbd6c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 62 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206119-001 PC 2022-09-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206119-001 PC 2022-09-06 5d02ea3f76ae…2023-01-26 05:58 UTC 2023-01 A206119-001 PC 2022-09-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206119-001 PC 2022-09-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206119-001 PC 2022-09-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206119-001 PC 2022-09-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206119-001 PC 2022-09-06 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Tolvaptan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLVAPTAN 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 21G72T1950 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 849827 Internal RxNorm lookup 849833 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 49884-770-52 Tolvaptan 10 in 1 BLISTER PACK TABLET 10 8 49884-770-54 Tolvaptan 1 in 1 CARTON TABLET 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49884-770 TOLVAPTAN TABLET [ENDO USA, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20240926_5b14ba2b-9f80-41d6-9613-f16d3cf37d25.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 49884-770-52 49884077052 10 in 1 BLISTER PACK Historical 49884-770-54 49884077054 1 BLISTER PACK in 1 CARTON (49884-770-54) / 10 TABLET in 1 BLISTER PACK (49884-770-52) 1 blister pack 2022-03-10 0000-00-00 No No Current