Home NDC 60505-4804 Tolvaptan
Product NDC 60505-4804
11-digit product format 605054804
Labeler code 60505
Product ID 60505-4804_b95d7f1e-ec8c-70cc-281f-074402f0c2ca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tolvaptan
Dosage form KIT
Route ORAL
Labeler Apotex Corp.
Application ANDA218381
Marketing category ANDA
Marketing start 2026-08-06
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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218381-001 TOLVAPTAN TOLVAPTAN 15MG TABLET / ORAL AB2 2025-11-10 A218381-002 TOLVAPTAN TOLVAPTAN 30MG TABLET / ORAL AB2 2025-11-10 A218381-003 TOLVAPTAN TOLVAPTAN 45MG TABLET / ORAL AB2 2025-11-10 A218381-004 TOLVAPTAN TOLVAPTAN 60MG TABLET / ORAL AB2 2025-11-10 A218381-005 TOLVAPTAN TOLVAPTAN 90MG TABLET / ORAL AB2 2025-11-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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.
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 A218381-001 TOLVAPTAN 15MG TABLET / ORAL AB2 2025-11-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218381-002 TOLVAPTAN 30MG TABLET / ORAL AB2 2025-11-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218381-003 TOLVAPTAN 45MG TABLET / ORAL AB2 2025-11-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218381-004 TOLVAPTAN 60MG TABLET / ORAL AB2 2025-11-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218381-005 TOLVAPTAN 90MG TABLET / ORAL AB2 2025-11-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218381-001 TOLVAPTAN 15MG TABLET / ORAL AB2 2025-11-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218381-002 TOLVAPTAN 30MG TABLET / ORAL AB2 2025-11-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218381-003 TOLVAPTAN 45MG TABLET / ORAL AB 2025-11-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218381-004 TOLVAPTAN 60MG TABLET / ORAL AB2 2025-11-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218381-005 TOLVAPTAN 90MG TABLET / ORAL AB 2025-11-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218381-001 TOLVAPTAN 15MG TABLET / ORAL AB2 2025-11-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218381-002 TOLVAPTAN 30MG TABLET / ORAL AB2 2025-11-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218381-003 TOLVAPTAN 45MG TABLET / ORAL AB 2025-11-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218381-004 TOLVAPTAN 60MG TABLET / ORAL AB2 2025-11-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218381-005 TOLVAPTAN 90MG TABLET / ORAL AB 2025-11-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218381-001 TOLVAPTAN 15MG TABLET / ORAL AB2 2025-11-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218381-002 TOLVAPTAN 30MG TABLET / ORAL AB2 2025-11-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218381-003 TOLVAPTAN 45MG TABLET / ORAL AB 2025-11-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218381-004 TOLVAPTAN 60MG TABLET / ORAL AB2 2025-11-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218381-005 TOLVAPTAN 90MG TABLET / ORAL AB 2025-11-10 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218381-001 TOLVAPTAN 15MG TABLET / ORAL AB2 2025-11-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218381-002 TOLVAPTAN 30MG TABLET / ORAL AB2 2025-11-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218381-003 TOLVAPTAN 45MG TABLET / ORAL AB 2025-11-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218381-004 TOLVAPTAN 60MG TABLET / ORAL AB2 2025-11-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218381-005 TOLVAPTAN 90MG TABLET / ORAL AB 2025-11-10 a50c72e98297…
Observed Orange Book normalized TE history# 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 Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60505-4804-0 60505480400 4 BLISTER PACK in 1 CARTON (60505-4804-0) / 1 KIT in 1 BLISTER PACK (60505-4804-1) 4 blister pack 2026-08-06 No No Current