Tolterodine Tartrate

Orange BookUNIISPLATC G04BD07

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.

CountryUS (United States)

ATC codeG04BD07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
0093716305
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-7163-05)
ndc11
0093716356
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-7163-56)
ndc11
0093716398
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-7163-98)

Annotations

UNII (FDA Substance ID)

5T619TQR3R

TOLTERODINE TARTRATE

RxCUI 221174

Orange Book

A079141

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": "0093-7163_acae7de6-a2b9-4475-8b25-620c0fa55235",
  "productndc": "0093-7163",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "079141",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Nov 22, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "002",
        "approval_date": "Nov 22, 2016"
      }
    ],
    "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": "ANDA079141",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tolterodine Tartrate",
  "start_marketing_date": "20170320",
  "active_numerator_strength": "2"
}

Related drugs

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