Home NDC 60505-4317 tolvaptan
Product NDC 60505-4317
11-digit product format 605054317
Labeler code 60505
Product ID 60505-4317_f0a587b3-af44-097a-8e8a-8cfd15676e33
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tolvaptan
Dosage form TABLET
Route ORAL
Labeler Apotex Corp.
Application ANDA207605
Marketing category ANDA
Marketing start 2022-12-14
Substance TOLVAPTAN
Active strength 15 mg/1
Pharmacologic classes Vasopressin V2 Receptor Antagonist [EPC], Vasopressin V2 Receptor Antagonists [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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207605-001 TOLVAPTAN TOLVAPTAN 30MG TABLET / ORAL AB1 2020-05-19 A207605-002 TOLVAPTAN TOLVAPTAN 15MG TABLET / ORAL AB1 2022-09-06
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 · 68 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 2026-09-14 22:38:34 2026-08 A207605-001 TOLVAPTAN 30MG TABLET / ORAL AB1 2020-05-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207605-002 TOLVAPTAN 15MG TABLET / ORAL AB1 2022-09-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207605-001 TOLVAPTAN 30MG TABLET / ORAL AB1 2020-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207605-002 TOLVAPTAN 15MG TABLET / ORAL AB1 2022-09-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207605-001 TOLVAPTAN 30MG TABLET / ORAL AB1 2020-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207605-002 TOLVAPTAN 15MG TABLET / ORAL AB1 2022-09-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207605-001 TOLVAPTAN 30MG TABLET / ORAL AB1 2020-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207605-002 TOLVAPTAN 15MG TABLET / ORAL AB1 2022-09-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207605-001 TOLVAPTAN 30MG TABLET / ORAL AB1 2020-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207605-002 TOLVAPTAN 15MG TABLET / ORAL AB1 2022-09-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207605-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207605-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207605-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207605-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207605-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207605-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207605-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207605-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207605-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207605-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207605-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207605-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207605-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207605-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207605-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207605-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207605-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207605-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207605-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207605-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207605-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207605-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207605-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207605-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207605-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A207605-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207605-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207605-001 TOLVAPTAN 30MG TABLET / ORAL 2020-05-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207605-001 TOLVAPTAN 30MG TABLET / ORAL 2020-05-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207605-001 TOLVAPTAN 30MG TABLET / ORAL 2020-05-19 8869cabd3fbd…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 65 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 tolvaptan
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLVAPTAN 15 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-4317-0 tolvaptan 10 in 1 BLISTER PACK TABLET 10 8 60505-4317-0 tolvaptan 1 in 1 CARTON TABLET 1 8 60505-4317-3 tolvaptan 30 in 1 BOTTLE TABLET 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-4317 TOLVAPTAN TABLET [APOTEX CORP.] 7 Current NDC, Legacy NDC, 3 package rows 20241003_d9fd11d0-4269-12fb-95cf-b3c11d75e479.zip
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 60505-4317-0 60505431700 1 BLISTER PACK in 1 CARTON (60505-4317-0) / 10 TABLET in 1 BLISTER PACK 1 blister pack 2022-12-14 0000-00-00 No No Current 60505-4317-3 60505431703 30 TABLET in 1 BOTTLE (60505-4317-3) 30 tablet 2022-12-14 0000-00-00 No No Current