Tolvaptan

Product NDC: 0480-3314
Requested package NDC: 0480-3314-66
11-digit product format: 004803314
Labeler code: 0480
Product ID: 0480-3314_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	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.

Application-product, TE code table
Application-product	TE code
A216933-001	AB2
A216933-002	AB2
A216933-003	AB2
A216933-004	AB2
A216933-005	AB2

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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216933-001	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216933-002	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216933-003	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216933-004	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216933-005	AB2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216933-001	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216933-002	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216933-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216933-004	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216933-005	AB	1	`caaa826d4ba7…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
808a9a1f-2f58-4677-9127-e749ad007094	Available on FDA.report

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tolvaptan	TOLVAPTAN	Teva Pharmaceuticals, Inc.	808a9a1f-2f58-4677-9127-e749ad007094	2025-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216933 application number: ANDA216933 ndc (package): 0480-3314-66 ndc (product): 0480-3314 ndc11 (package): 00480331466

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
21G72T1950	TOLVAPTAN	150683-30-0	Tolvaptan

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0480-3314-66	00480331466	4 BLISTER PACK in 1 CARTON (0480-3314-66) / 1 KIT in 1 BLISTER PACK (0480-3314-14) * 7 TABLET in 1 BLISTER PACK (0480-4099-11) * 7 TABLET in 1 BLISTER PACK (0480-3266-11)	4 blister pack	2026-08-27	No	No	Current