FDA.reportPublic FDA data

Tolvaptan

Product NDC
31722-868
11-digit product format
317220868
Labeler code
31722
Product ID
31722-868_e7e86fa1-8352-5245-e053-2995a90a70f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolvaptan
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA205646
Marketing category
ANDA
Marketing start
2022-09-06
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

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 Identifiers#

Field, Values table
FieldValues
Unii21G72T1950
Rxcui849827, 849833

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
31722-868-01Tolvaptan10 in 1 BLISTER PACKTABLET102
31722-868-01Tolvaptan10 in 1 CARTONTABLET102
31722-868-02Tolvaptan10 in 1 BLISTER PACKTABLET102
31722-868-02Tolvaptan10 in 1 CARTONTABLET102
31722-868-03Tolvaptan1 in 1 CARTONTABLET12
31722-868-03Tolvaptan10 in 1 BLISTER PACKTABLET102
31722-868-04Tolvaptan10 in 1 BLISTER PACKTABLET102
31722-868-04Tolvaptan1 in 1 CARTONTABLET12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-868-03EA - Each31722-86851cc7ce6-29d6-491c-b4d2-2f857503a91d12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-868TOLVAPTAN (TOLVAPTAN) TABLET [CAMBER PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 8 package rows20220906_6f4c5679-8490-45ec-bd34-1a569e3af850.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849827tolvaptan 15 MG Hyponatremia Oral TabletPSN6f4c5679-8490-45ec-bd34-1a569e3af8502
849833tolvaptan 30 MG Hyponatremia Oral TabletPSN6f4c5679-8490-45ec-bd34-1a569e3af8502
849827Hyponatremia tolvaptan 15 MG Oral TabletSCD6f4c5679-8490-45ec-bd34-1a569e3af8502
849833Hyponatremia tolvaptan 30 MG Oral TabletSCD6f4c5679-8490-45ec-bd34-1a569e3af8502
849827tolvaptan 15 MG Hyponatremia Oral TabletSY6f4c5679-8490-45ec-bd34-1a569e3af8502
849833tolvaptan 30 MG Hyponatremia Oral TabletSY6f4c5679-8490-45ec-bd34-1a569e3af8502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-868-013172208680110 BLISTER PACK in 1 CARTON (31722-868-01) / 10 TABLET in 1 BLISTER PACK10 blister pack2022-09-060000-00-00NoNoCurrent
31722-868-023172208680210 BLISTER PACK in 1 CARTON (31722-868-02) / 10 TABLET in 1 BLISTER PACK10 blister pack2022-09-060000-00-00NoNoCurrent
31722-868-03317220868031 BLISTER PACK in 1 CARTON (31722-868-03) / 10 TABLET in 1 BLISTER PACK1 blister pack2022-09-060000-00-00NoNoCurrent
31722-868-04317220868041 BLISTER PACK in 1 CARTON (31722-868-04) / 10 TABLET in 1 BLISTER PACK1 blister pack2022-09-060000-00-00NoNoCurrent