TOLVAPTAN

Orange BookSPL

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

Identification

ManufacturerLupin Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7074824413
4 BLISTER PACK in 1 CARTON (70748-244-13) / 1 KIT in 1 BLISTER PACK (70748-244-11)

Annotations

Orange Book

A216063

AB2AB2ABAB2AB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "70748-244_3e110564-6fd2-4450-a3d2-a5de70b85f2d",
  "productndc": "70748-244",
  "dosage_form": "KIT",
  "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": null,
  "proprietary_name": "TOLVAPTAN",
  "active_ingred_unit": null,
  "application_number": "ANDA216063",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TOLVAPTAN",
  "start_marketing_date": "20250512",
  "active_numerator_strength": null
}

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