FDA.reportPublic FDA data

TOLVAPTAN

Product NDC
72205-130
Requested package NDC
72205-130-11
11-digit product format
722050130
Labeler code
72205
Product ID
72205-130_92ce12f1-eae0-4c83-9a4e-a5181e08fa92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOLVAPTAN
Dosage form
TABLET
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA216949
Marketing category
ANDA
Marketing start
2023-06-21
Substance
TOLVAPTAN
Active strength
15 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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216949-001TOLVAPTANTOLVAPTAN15MGTABLET / ORALAB12023-06-21
A216949-002TOLVAPTANTOLVAPTAN30MGTABLET / ORALAB12023-06-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A216949-001AB1
A216949-002AB1

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A216949-001TOLVAPTAN15MGTABLET / ORALAB12023-06-21a50c72e98297…
2026-08-01 22:54:322026-06A216949-002TOLVAPTAN30MGTABLET / ORALAB12023-06-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A216949-001AB11a50c72e98297…
2026-08-01 22:54:322026-06A216949-002AB11a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOLVAPTANTOLVAPTANNorthstar Rx LLCc075d517-f4c8-469a-9f51-416ef61c6a832026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216949
application number: ANDA216949
TOLVAPTANTOLVAPTANNovadoz Pharmaceuticals LLC92ce12f1-eae0-4c83-9a4e-a5181e08fa922023-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216949
application number: ANDA216949
ndc (package): 72205-130-11
ndc (product): 72205-130
ndc11 (package): 72205013011

Additional Listing Data#

Finished product
Yes
Brand name base
TOLVAPTAN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLVAPTAN15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
21G72T1950Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
849827Internal RxNorm lookup
849833Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92ce12f1-eae0-4c83-9a4e-a5181e08fa92Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7f9e53d9-c2b2-4ac0-9989-193b7a2ecee6Product name220250805
48801b9b-adbb-003d-f253-aa66331fded9Product name520240730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-130-11TOLVAPTAN10 in 1 BLISTER PACKTABLET101
72205-130-11TOLVAPTAN1 in 1 CARTONTABLET11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-130-11EA - Each72205-1307edfb434-a8fb-4653-9673-2c21fd25cb8412024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-130TOLVAPTAN TABLET [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, 2 package rows20231004_92ce12f1-eae0-4c83-9a4e-a5181e08fa92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849827tolvaptan 15 MG Hyponatremia Oral TabletPSN92ce12f1-eae0-4c83-9a4e-a5181e08fa921
849833tolvaptan 30 MG Hyponatremia Oral TabletPSN92ce12f1-eae0-4c83-9a4e-a5181e08fa921
849827Hyponatremia tolvaptan 15 MG Oral TabletSCD92ce12f1-eae0-4c83-9a4e-a5181e08fa921
849833Hyponatremia tolvaptan 30 MG Oral TabletSCD92ce12f1-eae0-4c83-9a4e-a5181e08fa921
849827tolvaptan 15 MG Hyponatremia Oral TabletSY92ce12f1-eae0-4c83-9a4e-a5181e08fa921
849833tolvaptan 30 MG Hyponatremia Oral TabletSY92ce12f1-eae0-4c83-9a4e-a5181e08fa921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-130-11722050130111 BLISTER PACK in 1 CARTON (72205-130-11) / 10 TABLET in 1 BLISTER PACK1 blister pack2023-09-26NoNoCurrent