Home NDC 0480-3313 Tolvaptan
Product NDC 0480-3313
11-digit product format 004803313
Labeler code 0480
Product ID 0480-3313_55f269ec-f4f3-48c0-a7ea-b5d8a97344d9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tolvaptan
Dosage form KIT
Labeler Teva Pharmaceuticals, Inc.
Application ANDA216933
Marketing category ANDA
Marketing start 2026-08-27
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 A216933-001 TOLVAPTAN TOLVAPTAN 15MG TABLET / ORAL AB2 2026-07-21 A216933-002 TOLVAPTAN TOLVAPTAN 30MG TABLET / ORAL AB2 2026-07-21 A216933-003 TOLVAPTAN TOLVAPTAN 45MG TABLET / ORAL AB2 2026-07-21 A216933-004 TOLVAPTAN TOLVAPTAN 60MG TABLET / ORAL AB2 2026-07-21 A216933-005 TOLVAPTAN TOLVAPTAN 90MG TABLET / ORAL AB2 2026-07-21
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 A216933-001 TOLVAPTAN 15MG TABLET / ORAL AB2 2026-07-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216933-002 TOLVAPTAN 30MG TABLET / ORAL AB2 2026-07-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216933-003 TOLVAPTAN 45MG TABLET / ORAL AB2 2026-07-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216933-004 TOLVAPTAN 60MG TABLET / ORAL AB2 2026-07-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216933-005 TOLVAPTAN 90MG TABLET / ORAL AB2 2026-07-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216933-001 TOLVAPTAN 15MG TABLET / ORAL AB2 2026-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216933-002 TOLVAPTAN 30MG TABLET / ORAL AB2 2026-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216933-003 TOLVAPTAN 45MG TABLET / ORAL AB 2026-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216933-004 TOLVAPTAN 60MG TABLET / ORAL AB2 2026-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216933-005 TOLVAPTAN 90MG TABLET / ORAL AB 2026-07-21 caaa826d4ba7…
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 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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0480-3313-66 00480331366 4 BLISTER PACK in 1 CARTON (0480-3313-66) / 1 KIT in 1 BLISTER PACK (0480-3313-14) * 7 TABLET in 1 BLISTER PACK (0480-4093-11) * 7 TABLET in 1 BLISTER PACK (0480-3266-11) 4 blister pack 2026-08-27 No No Current