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United States · US · US:0093-0010_2f429822-d6d2-43c0-9aaf-1270b3e92a2f

Tolterodine Tartrate

Orange BookUNIISPLATC G04BD07

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

Identification

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

Packs · 1

  • ndc11
    0093001006
    60 TABLET, FILM COATED in 1 BOTTLE (0093-0010-06)

Annotations

UNII (FDA Substance ID)
5T619TQR3R
TOLTERODINE TARTRATE
RxCUI 221174
Orange Book
A077006
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": "0093-0010_2f429822-d6d2-43c0-9aaf-1270b3e92a2f",
  "productndc": "0093-0010",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077006",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Feb 23, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Feb 23, 2015"
      }
    ],
    "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": "ANDA077006",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tolterodine Tartrate",
  "start_marketing_date": "20151101",
  "active_numerator_strength": "1"
}

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