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United States · US · US:27241-191_cf018a04-660f-4119-898f-1877a5db8e7e

Tolterodine tartrate

Orange BookUNIISPLATC G04BD07

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAjanta Pharma USA Inc.
CountryUS (United States)
ATC codeG04BD07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    2724119105
    500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-191-05)
  • ndc11
    2724119130
    30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-191-30)
  • ndc11
    2724119190
    90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-191-90)

Annotations

UNII (FDA Substance ID)
5T619TQR3R
TOLTERODINE TARTRATE
RxCUI 221174
Orange Book
A213397
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "5T619TQR3R",
    "rxcui": "221174",
    "inchikey": "TWHNMSJGYKMTRB-KXYUELECSA-N",
    "display_name": "TOLTERODINE TARTRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "da9423b5-00ab-46fc-8959-3db3c0a0bc6d": {
      "match": "brand_token",
      "title": "TOLTERODINE TARTRATE (TOLTERODINE) CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]",
      "spl_version": "9",
      "published_date": "2026-03-20"
    }
  },
  "productid": "27241-191_cf018a04-660f-4119-898f-1877a5db8e7e",
  "productndc": "27241-191",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "213397",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "May 19, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "002",
        "approval_date": "May 19, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOLTERODINE TARTRATE",
  "proprietary_name": "Tolterodine tartrate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213397",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tolterodine tartrate",
  "start_marketing_date": "20200625",
  "active_numerator_strength": "2"
}

Related drugs

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