Home NDC 72603-933 TOLVAPTAN
Product NDC 72603-933
11-digit product format 726030933
Labeler code 72603
Product ID 72603-933_3dd69146-6f15-4c54-a6d9-7408e6c41548
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TOLVAPTAN
Dosage form TABLET
Route ORAL
Labeler Northstar Rx LLC
Application ANDA216949
Marketing category ANDA
Marketing start 2023-06-21
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A216949-001 TOLVAPTAN TOLVAPTAN 15MG TABLET / ORAL AB1 2023-06-21 A216949-002 TOLVAPTAN TOLVAPTAN 30MG TABLET / ORAL AB1 2023-06-21
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 · 44 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 2026-08-18 06:07:40 2026-07 A216949-001 TOLVAPTAN 15MG TABLET / ORAL AB1 2023-06-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216949-002 TOLVAPTAN 30MG TABLET / ORAL AB1 2023-06-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216949-001 TOLVAPTAN 15MG TABLET / ORAL AB1 2023-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216949-002 TOLVAPTAN 30MG TABLET / ORAL AB1 2023-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216949-001 TOLVAPTAN 15MG TABLET / ORAL AB1 2023-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216949-002 TOLVAPTAN 30MG TABLET / ORAL AB1 2023-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216949-001 TOLVAPTAN 15MG TABLET / ORAL AB1 2023-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216949-002 TOLVAPTAN 30MG TABLET / ORAL AB1 2023-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216949-001 TOLVAPTAN 15MG TABLET / ORAL AB 2023-06-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216949-002 TOLVAPTAN 30MG TABLET / ORAL AB 2023-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216949-001 TOLVAPTAN 15MG TABLET / ORAL AB 2023-06-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216949-002 TOLVAPTAN 30MG TABLET / ORAL AB 2023-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216949-001 TOLVAPTAN 15MG TABLET / ORAL AB 2023-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216949-002 TOLVAPTAN 30MG TABLET / ORAL AB 2023-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216949-001 TOLVAPTAN 15MG TABLET / ORAL AB 2023-06-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216949-002 TOLVAPTAN 30MG TABLET / ORAL AB 2023-06-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216949-001 TOLVAPTAN 15MG TABLET / ORAL AB 2023-06-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216949-002 TOLVAPTAN 30MG TABLET / ORAL AB 2023-06-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216949-001 TOLVAPTAN 15MG TABLET / ORAL AB 2023-06-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216949-002 TOLVAPTAN 30MG TABLET / ORAL AB 2023-06-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216949-001 TOLVAPTAN 15MG TABLET / ORAL AB 2023-06-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216949-002 TOLVAPTAN 30MG TABLET / ORAL AB 2023-06-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216949-001 TOLVAPTAN 15MG TABLET / ORAL AB 2023-06-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216949-002 TOLVAPTAN 30MG TABLET / ORAL AB 2023-06-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216949-001 TOLVAPTAN 15MG TABLET / ORAL AB 2023-06-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216949-002 TOLVAPTAN 30MG TABLET / ORAL AB 2023-06-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216949-001 TOLVAPTAN 15MG TABLET / ORAL AB 2023-06-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216949-002 TOLVAPTAN 30MG TABLET / ORAL AB 2023-06-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216949-001 TOLVAPTAN 15MG TABLET / ORAL AB 2023-06-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216949-002 TOLVAPTAN 30MG TABLET / ORAL AB 2023-06-21 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216949-001 TOLVAPTAN 15MG TABLET / ORAL AB 2023-06-21 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216949-002 TOLVAPTAN 30MG TABLET / ORAL AB 2023-06-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216949-001 TOLVAPTAN 15MG TABLET / ORAL AB 2023-06-21 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216949-002 TOLVAPTAN 30MG TABLET / ORAL AB 2023-06-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216949-001 TOLVAPTAN 15MG TABLET / ORAL AB 2023-06-21 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A216949-002 TOLVAPTAN 30MG TABLET / ORAL AB 2023-06-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216949-001 TOLVAPTAN 15MG TABLET / ORAL AB 2023-06-21 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216949-002 TOLVAPTAN 30MG TABLET / ORAL AB 2023-06-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216949-001 TOLVAPTAN 15MG TABLET / ORAL AB 2023-06-21 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216949-002 TOLVAPTAN 30MG TABLET / ORAL AB 2023-06-21 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Additional Listing Data#
Finished product Yes
Brand name base TOLVAPTAN
Listing expiration 2027-12-31 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 72603-933-01 TOLVAPTAN 10 in 1 BLISTER PACK TABLET 10 3 72603-933-01 TOLVAPTAN 1 in 1 CARTON TABLET 1 3
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 72603-933-01 72603093301 1 BLISTER PACK in 1 CARTON (72603-933-01) / 10 TABLET in 1 BLISTER PACK 1 blister pack 2026-07-01 0 Current