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United States · US · US:31722-806_c9a8a649-3330-59a0-e053-2995a90ad3c3

Tolterodine Tartrate

Orange BookUNIISPLATC G04BD07

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

Identification

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

Packs · 4

  • ndc11
    3172280601
    10 BLISTER PACK in 1 CARTON (31722-806-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-806-31)
  • ndc11
    3172280602
    10 BLISTER PACK in 1 CARTON (31722-806-02) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-806-32)
  • ndc11
    3172280605
    500 TABLET, FILM COATED in 1 BOTTLE (31722-806-05)
  • ndc11
    3172280660
    60 TABLET, FILM COATED in 1 BOTTLE (31722-806-60)

Annotations

UNII (FDA Substance ID)
5T619TQR3R
TOLTERODINE TARTRATE
RxCUI 221174
Orange Book
A204397
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": "31722-806_c9a8a649-3330-59a0-e053-2995a90ad3c3",
  "productndc": "31722-806",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204397",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Aug 2, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Aug 2, 2021"
      }
    ],
    "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": "ANDA204397",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tolterodine Tartrate",
  "start_marketing_date": "20210802",
  "active_numerator_strength": "2"
}

Related drugs

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