FDA.reportPublic FDA data

SAMSCA

Product NDC
59148-021
11-digit product format
591480021
Labeler code
59148
Product ID
59148-021_701668e3-9542-46eb-b6c9-f7553d33385d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tolvaptan
Dosage form
TABLET
Route
ORAL
Labeler
Otsuka America Pharmaceutical, Inc.
Application
NDA022275
Marketing category
NDA
Marketing start
2009-05-19
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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022275-001SAMSCATOLVAPTAN15MGTABLET / ORALAB1RLD2009-05-19
N022275-002SAMSCATOLVAPTAN30MGTABLET / ORALAB1RLD, RS2009-05-19
N022275-003SAMSCATOLVAPTAN60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-05-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N022275-001AB1
N022275-002AB1

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022275-00185017302026-09-01Drug substance2013-09-27
N022275-001109056942030-04-07Drug product2021-02-26
N022275-00285017302026-09-01Drug substance2013-09-27
N022275-002109056942030-04-07Drug product2021-02-26
N022275-00385017302026-09-01Drug substance2013-09-27
N022275-003109056942030-04-07Drug product2021-02-26

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 22:54:322026-06N022275-001SAMSCA15MGTABLET / ORALAB1RLD2009-05-19a50c72e98297…
2026-08-01 22:54:322026-06N022275-002SAMSCA30MGTABLET / ORALAB1RLD, RS2009-05-19a50c72e98297…
2026-08-01 22:54:322026-06N022275-003SAMSCA60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2009-05-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N022275-001AB11a50c72e98297…
2026-08-01 22:54:322026-06N022275-002AB11a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N022275-00185017302026-09-01Drug substance2013-09-27a50c72e98297…
2026-08-01 22:54:322026-06N022275-001109056942030-04-07Drug product2021-02-26a50c72e98297…
2026-08-01 22:54:322026-06N022275-00285017302026-09-01Drug substance2013-09-27a50c72e98297…
2026-08-01 22:54:322026-06N022275-002109056942030-04-07Drug product2021-02-26a50c72e98297…
2026-08-01 22:54:322026-06N022275-00385017302026-09-01Drug substance2013-09-27a50c72e98297…
2026-08-01 22:54:322026-06N022275-003109056942030-04-07Drug product2021-02-26a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SAMSCATOLVAPTANOtsuka America Pharmaceutical, Inc.5526617c-c7b9-4556-886d-729bbabbc5662026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022275
application number: NDA022275
ndc (product): 59148-021

Additional Listing Data#

Finished product
Yes
Brand name base
SAMSCA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLVAPTAN30 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
849827Internal RxNorm lookup
849831Internal RxNorm lookup
849833Internal RxNorm lookup
849835Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5526617c-c7b9-4556-886d-729bbabbc566Available 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
59148-021-50SAMSCA10 in 1 BLISTER PACKTABLET1022
59148-021-50SAMSCA1 in 1 CARTONTABLET122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59148-021-50EA - Each59148-02188b0a932-1045-4bc0-add9-8ec7c9fccf2f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
tolvaptanACTIVE INGREDIENT21G72T1950SAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL INC.]11
tolvaptanACTIVE MOIETY21G72T1950SAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL INC.]11
Aluminum OxideINACTIVE INGREDIENTLMI26O6933SAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL INC.]11
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61USAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL INC.]11
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKSAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL INC.]11
hydroxypropyl cellulose (type h)INACTIVE INGREDIENTRFW2ET671PSAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL INC.]11
hydroxypropyl cellulose, low substitutedINACTIVE INGREDIENT2165RE0K14SAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL INC.]11
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XSAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL INC.]11
magnesium stearateINACTIVE INGREDIENT70097M6I30SAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL INC.]11
starch, cornINACTIVE INGREDIENTO8232NY3SJSAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59148-021SAMSCA (TOLVAPTAN) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]21Current NDC, Legacy NDC, 2 package rows20221119_5526617c-c7b9-4556-886d-729bbabbc566.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849831Samsca 15 MG Oral TabletPSN5526617c-c7b9-4556-886d-729bbabbc56623
849835Samsca 30 MG Oral TabletPSN5526617c-c7b9-4556-886d-729bbabbc56623
849827tolvaptan 15 MG Hyponatremia Oral TabletPSN5526617c-c7b9-4556-886d-729bbabbc56623
849833tolvaptan 30 MG Hyponatremia Oral TabletPSN5526617c-c7b9-4556-886d-729bbabbc56623
849831Hyponatremia tolvaptan 15 MG Oral Tablet [Samsca]SBD5526617c-c7b9-4556-886d-729bbabbc56623
849835Hyponatremia tolvaptan 30 MG Oral Tablet [Samsca]SBD5526617c-c7b9-4556-886d-729bbabbc56623
849827Hyponatremia tolvaptan 15 MG Oral TabletSCD5526617c-c7b9-4556-886d-729bbabbc56623
849833Hyponatremia tolvaptan 30 MG Oral TabletSCD5526617c-c7b9-4556-886d-729bbabbc56623
849831Hyponatremia Samsca 15 MG Oral TabletSY5526617c-c7b9-4556-886d-729bbabbc56623
849835Hyponatremia Samsca 30 MG Oral TabletSY5526617c-c7b9-4556-886d-729bbabbc56623
849831Samsca 15 MG Hyponatremia Oral TabletSY5526617c-c7b9-4556-886d-729bbabbc56623
849835Samsca 30 MG Hyponatremia Oral TabletSY5526617c-c7b9-4556-886d-729bbabbc56623
849827tolvaptan 15 MG Hyponatremia Oral TabletSY5526617c-c7b9-4556-886d-729bbabbc56623
849833tolvaptan 30 MG Hyponatremia Oral TabletSY5526617c-c7b9-4556-886d-729bbabbc56623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59148-021-50591480021501 BLISTER PACK in 1 CARTON (59148-021-50) / 10 TABLET in 1 BLISTER PACK1 blister pack2009-05-190000-00-00NoNoCurrent