TOLTERODINE TARTRATE

Orange BookUNIISPLATC G04BD07

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

Identification

ManufacturerTorrent Pharmaceuticals Limited

CountryUS (United States)

ATC codeG04BD07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
1366818905
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-189-05)
ndc11
1366818930
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-189-30)
ndc11
1366818974
100 CAPSULE, EXTENDED RELEASE in 1 CARTON (13668-189-74)
ndc11
1366818990
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-189-90)

Annotations

UNII (FDA Substance ID)

5T619TQR3R

TOLTERODINE TARTRATE

RxCUI 221174

Orange Book

A203016

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": "13668-189_de456fdd-b0a2-4b65-b926-bb9948fde276",
  "productndc": "13668-189",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "203016",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Aug 11, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "002",
        "approval_date": "Aug 11, 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": "ANDA203016",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TOLTERODINE",
  "start_marketing_date": "20150811",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code G04BD07.

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