Home NDC 31722-869 Tolvaptan
Product NDC 31722-869
11-digit product format 317220869
Labeler code 31722
Product ID 31722-869_e7e86fa1-8352-5245-e053-2995a90a70f6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tolvaptan
Dosage form TABLET
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA205646
Marketing category ANDA
Marketing start 2021-07-16
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 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 A205646-001 TOLVAPTAN TOLVAPTAN 30MG TABLET / ORAL AB1 2021-07-16 A205646-002 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 · 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 2026-08-18 06:07:40 2026-07 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB1 2021-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205646-002 TOLVAPTAN 15MG TABLET / ORAL AB1 2022-09-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB1 2021-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205646-002 TOLVAPTAN 15MG TABLET / ORAL AB1 2022-09-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB1 2021-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205646-002 TOLVAPTAN 15MG TABLET / ORAL AB1 2022-09-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB1 2021-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205646-002 TOLVAPTAN 15MG TABLET / ORAL AB1 2022-09-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB 2021-07-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205646-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB 2021-07-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205646-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB 2021-07-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205646-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB 2021-07-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205646-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB 2021-07-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205646-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB 2021-07-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205646-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB 2021-07-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205646-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB 2021-07-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205646-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB 2021-07-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205646-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB 2021-07-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205646-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB 2021-07-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205646-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB 2021-07-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB 2021-07-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB 2021-07-16 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB 2021-07-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB 2021-07-16 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB 2021-07-16 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205646-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB 2021-07-16 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A205646-002 TOLVAPTAN 15MG TABLET / ORAL AB 2022-09-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205646-001 TOLVAPTAN 30MG TABLET / ORAL AB 2021-07-16 ea1830bbd6c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 62 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 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-869 TOLVAPTAN (TOLVAPTAN) TABLET [CAMBER PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 8 package rows 20220906_6f4c5679-8490-45ec-bd34-1a569e3af850.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 31722-869-01 31722086901 10 BLISTER PACK in 1 CARTON (31722-869-01) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2021-07-16 0000-00-00 No No Current 31722-869-02 31722086902 10 BLISTER PACK in 1 CARTON (31722-869-02) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2021-07-16 0000-00-00 No No Current 31722-869-03 31722086903 1 BLISTER PACK in 1 CARTON (31722-869-03) / 10 TABLET in 1 BLISTER PACK 1 blister pack 2021-07-16 0000-00-00 No No Current 31722-869-04 31722086904 1 BLISTER PACK in 1 CARTON (31722-869-04) / 10 TABLET in 1 BLISTER PACK 1 blister pack 2021-07-16 0000-00-00 No No Current