Tolterodine Tartrate

Orange BookUNIISPLATC G04BD07

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

Identification

ManufacturerUnichem Pharmaceuticals (USA), Inc.

CountryUS (United States)

ATC codeG04BD07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
2930024001
100 TABLET in 1 BOTTLE, PLASTIC (29300-240-01)
ndc11
2930024005
500 TABLET in 1 BOTTLE, PLASTIC (29300-240-05)
ndc11
2930024013
30 TABLET in 1 BOTTLE, PLASTIC (29300-240-13)
ndc11
2930024016
60 TABLET in 1 BOTTLE, PLASTIC (29300-240-16)
ndc11
2930024019
90 TABLET in 1 BOTTLE, PLASTIC (29300-240-19)

Annotations

UNII (FDA Substance ID)

5T619TQR3R

TOLTERODINE TARTRATE

RxCUI 221174

Orange Book

A205399

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": "29300-240_9faf1be0-1f13-47c0-b2aa-3ad62e5037e9",
  "productndc": "29300-240",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205399",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Aug 5, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Aug 5, 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": "ANDA205399",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tolterodine Tartrate",
  "start_marketing_date": "20200805",
  "active_numerator_strength": "2"
}

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