Home NDC 70748-241 TOLVAPTAN
Product NDC 70748-241
11-digit product format 707480241
Labeler code 70748
Product ID 70748-241_3e110564-6fd2-4450-a3d2-a5de70b85f2d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TOLVAPTAN
Dosage form KIT
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA216063
Marketing category ANDA
Marketing start 2025-05-12
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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216063-001 TOLVAPTAN TOLVAPTAN 15MG TABLET / ORAL AB2 2025-04-23 A216063-002 TOLVAPTAN TOLVAPTAN 30MG TABLET / ORAL AB2 2025-04-23 A216063-003 TOLVAPTAN TOLVAPTAN 45MG TABLET / ORAL AB 2025-04-23 A216063-004 TOLVAPTAN TOLVAPTAN 60MG TABLET / ORAL AB2 2025-04-23 A216063-005 TOLVAPTAN TOLVAPTAN 90MG TABLET / ORAL AB 2025-04-23
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 2026-08-18 06:07:40 2026-07 A216063-001 TOLVAPTAN 15MG TABLET / ORAL AB2 2025-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216063-002 TOLVAPTAN 30MG TABLET / ORAL AB2 2025-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216063-003 TOLVAPTAN 45MG TABLET / ORAL AB 2025-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216063-004 TOLVAPTAN 60MG TABLET / ORAL AB2 2025-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216063-005 TOLVAPTAN 90MG TABLET / ORAL AB 2025-04-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216063-001 TOLVAPTAN 15MG TABLET / ORAL AB2 2025-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216063-002 TOLVAPTAN 30MG TABLET / ORAL AB2 2025-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216063-003 TOLVAPTAN 45MG TABLET / ORAL AB 2025-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216063-004 TOLVAPTAN 60MG TABLET / ORAL AB2 2025-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216063-005 TOLVAPTAN 90MG TABLET / ORAL AB 2025-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216063-001 TOLVAPTAN 15MG TABLET / ORAL AB2 2025-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216063-002 TOLVAPTAN 30MG TABLET / ORAL AB2 2025-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216063-003 TOLVAPTAN 45MG TABLET / ORAL AB 2025-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216063-004 TOLVAPTAN 60MG TABLET / ORAL AB2 2025-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216063-005 TOLVAPTAN 90MG TABLET / ORAL AB 2025-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216063-001 TOLVAPTAN 15MG TABLET / ORAL AB2 2025-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216063-002 TOLVAPTAN 30MG TABLET / ORAL AB2 2025-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216063-003 TOLVAPTAN 45MG TABLET / ORAL AB 2025-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216063-004 TOLVAPTAN 60MG TABLET / ORAL AB2 2025-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216063-005 TOLVAPTAN 90MG TABLET / ORAL AB 2025-04-23 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216063-001 TOLVAPTAN 15MG TABLET / ORAL AB2 2025-04-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216063-002 TOLVAPTAN 30MG TABLET / ORAL AB2 2025-04-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216063-003 TOLVAPTAN 45MG TABLET / ORAL AB 2025-04-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216063-004 TOLVAPTAN 60MG TABLET / ORAL AB2 2025-04-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216063-005 TOLVAPTAN 90MG TABLET / ORAL AB 2025-04-23 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base TOLVAPTAN
Listing expiration 2026-12-31 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 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2044359 Internal RxNorm lookup 2044363 Internal RxNorm lookup 2044367 Internal RxNorm lookup 2044966 Internal RxNorm lookup 2044968 Internal RxNorm lookup 2044970 Internal RxNorm lookup 2274813 Internal RxNorm lookup 2274815 Internal RxNorm lookup 2719335 Internal RxNorm lookup 2719337 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 70748-241-11 TOLVAPTAN 1 in 1 BLISTER PACK KIT 1 6 70748-241-13 TOLVAPTAN 4 in 1 CARTON KIT 4 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70748-241 TOLVAPTAN ( TOLVAPTAN ) KIT TOLVAPTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 6 Current NDC, 2 package rows 20250513_9ba38e23-ca66-4406-92af-bbb8fad00e16.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# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2274813 {28 (tolvaptan 15 MG Oral Tablet) / 28 (tolvaptan 30 MG Oral Tablet) } Pack GPCK 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2044968 {28 (tolvaptan 15 MG Oral Tablet) / 28 (tolvaptan 45 MG Oral Tablet) } Pack GPCK 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2044966 {28 (tolvaptan 30 MG Oral Tablet) / 28 (tolvaptan 60 MG Oral Tablet) } Pack GPCK 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2044970 {28 (tolvaptan 30 MG Oral Tablet) / 28 (tolvaptan 90 MG Oral Tablet) } Pack GPCK 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2274815 {56 (tolvaptan 15 MG Oral Tablet) } Pack GPCK 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2274815 tolvaptan 15 MG / 15 MG Carton Pack PSN 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2719335 tolvaptan 15 MG Oral Tablet PSN 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2274813 tolvaptan 30 MG / 15 MG Carton Pack PSN 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2719337 tolvaptan 30 MG Oral Tablet PSN 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2044968 tolvaptan 45 MG / 15 MG Carton Pack PSN 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2044359 tolvaptan 45 MG Oral Tablet PSN 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2044966 tolvaptan 60 MG / 30 MG Carton Pack PSN 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2044363 tolvaptan 60 MG Oral Tablet PSN 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2044970 tolvaptan 90 MG / 30 MG Carton Pack PSN 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2044367 tolvaptan 90 MG Oral Tablet PSN 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2719335 tolvaptan 15 MG Oral Tablet SCD 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2719337 tolvaptan 30 MG Oral Tablet SCD 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2044359 tolvaptan 45 MG Oral Tablet SCD 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2044363 tolvaptan 60 MG Oral Tablet SCD 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2044367 tolvaptan 90 MG Oral Tablet SCD 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2274815 4 {14 (tolvaptan 15 MG Oral Tablet) } Carton Pack SY 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2274813 4 {7 (tolvaptan 30 MG Oral Tablet) / 7 (tolvaptan 15 MG Oral Tablet) } Carton Pack SY 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2044968 4 {7 (tolvaptan 45 MG Oral Tablet) / 7 (tolvaptan 15 MG Oral Tablet) } Carton Pack SY 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2044966 4 {7 (tolvaptan 60 MG Oral Tablet) / 7 (tolvaptan 30 MG Oral Tablet) } Carton Pack SY 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2044970 4 {7 (tolvaptan 90 MG Oral Tablet) / 7 (tolvaptan 30 MG Oral Tablet) } Carton Pack SY 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2274815 tolvaptan 15 MG / 15 MG Carton Pack, 4 Blister Cards, 14 Tablets Each SY 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2274813 tolvaptan 30 MG / 15 MG Carton Pack, 4 Blister Cards, 14 Tablets Each SY 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2044968 tolvaptan 45 MG / 15 MG Carton Pack, 4 Blister Cards, 14 Tablets Each SY 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2044966 tolvaptan 60 MG / 30 MG Carton Pack, 4 Blister Cards, 14 Tablets Each SY 9ba38e23-ca66-4406-92af-bbb8fad00e16 6 2044970 tolvaptan 90 MG / 30 MG Carton Pack, 4 Blister Cards, 14 Tablets Each SY 9ba38e23-ca66-4406-92af-bbb8fad00e16 6
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70748-241-11 70748024111 1 in 1 BLISTER PACK Historical 70748-241-13 70748024113 4 BLISTER PACK in 1 CARTON (70748-241-13) / 1 KIT in 1 BLISTER PACK (70748-241-11) 4 blister pack 2025-05-12 No No Current