TOLVAPTAN

Orange BookUNIISPLATC C03XA01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerLupin Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeC03XA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7074823906
30 TABLET in 1 BOTTLE (70748-239-06)

Annotations

UNII (FDA Substance ID)

21G72T1950

TOLVAPTAN

RxCUI 358257

Orange Book

A216063

AB2AB2ABAB2AB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "21G72T1950",
    "rxcui": "358257",
    "inchikey": "GYHCTFXIZSNGJT-UHFFFAOYSA-N",
    "display_name": "TOLVAPTAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c075d517-f4c8-469a-9f51-416ef61c6a83": {
      "match": "brand_token",
      "title": "TOLVAPTAN TABLET [NORTHSTAR RX LLC]",
      "spl_version": "3",
      "published_date": "2026-04-27"
    }
  },
  "productid": "70748-239_3e110564-6fd2-4450-a3d2-a5de70b85f2d",
  "productndc": "70748-239",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216063",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Apr 23, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Apr 23, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "45MG",
        "product_no": "003",
        "approval_date": "Apr 23, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "60MG",
        "product_no": "004",
        "approval_date": "Apr 23, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "90MG",
        "product_no": "005",
        "approval_date": "Apr 23, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOLVAPTAN",
  "proprietary_name": "TOLVAPTAN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216063",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TOLVAPTAN",
  "start_marketing_date": "20250512",
  "active_numerator_strength": "30"
}

Related drugs

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