Home NDC 67877-637 Tolvaptan
Product NDC 67877-637
11-digit product format 678770637
Labeler code 67877
Product ID 67877-637_f75355a8-50ef-4a88-aaa0-c85c0ae5c23d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tolvaptan
Dosage form TABLET
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA211891
Marketing category ANDA
Marketing start 2020-05-21
Substance TOLVAPTAN
Active strength 60 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 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211891-001 TOLVAPTAN TOLVAPTAN 30MG TABLET / ORAL AB1 2020-05-19 A211891-002 TOLVAPTAN TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 A211891-003 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 3 · 104 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 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB1 2020-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB1 2022-09-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB1 2020-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB1 2022-09-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB1 2020-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB1 2022-09-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB1 2020-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB1 2022-09-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211891-002 TOLVAPTAN 60MG TABLET / ORAL 2020-05-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211891-003 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211891-001 TOLVAPTAN 30MG TABLET / ORAL AB 2020-05-19 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 70 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tolvaptan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLVAPTAN 60 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 849827 Internal RxNorm lookup 849833 Internal RxNorm lookup 2044363 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 67877-637-01 Tolvaptan 100 in 1 BOTTLE TABLET 100 10 67877-637-02 Tolvaptan 10 in 1 BOTTLE TABLET 10 10 67877-637-33 Tolvaptan 10 in 1 BLISTER PACK TABLET 10 10 67877-637-33 Tolvaptan 1 in 1 CARTON TABLET 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-637 TOLVAPTAN TABLET [ASCEND LABORATORIES, LLC] 10 Current NDC, Legacy NDC, 4 package rows 20220909_dd71ee70-9435-4715-bee5-edbb5a8d7d7b.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 67877-637-01 67877063701 100 TABLET in 1 BOTTLE (67877-637-01) 100 tablet 2020-05-21 0000-00-00 No No Current 67877-637-02 67877063702 10 TABLET in 1 BOTTLE (67877-637-02) 10 tablet 2020-05-21 0000-00-00 No No Current 67877-637-33 67877063733 1 BLISTER PACK in 1 CARTON (67877-637-33) / 10 TABLET in 1 BLISTER PACK 1 blister pack 2020-05-21 0000-00-00 No No Current