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United States · US · US:71205-217_668d5539-1561-457c-9a7c-38784a9b5c66

Tamsulosin Hydrochloride

Orange BookUNIISPLATC G04CA02

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeG04CA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    7120521707
    7 CAPSULE in 1 BOTTLE (71205-217-07)
  • ndc11
    7120521714
    14 CAPSULE in 1 BOTTLE (71205-217-14)
  • ndc11
    7120521730
    30 CAPSULE in 1 BOTTLE (71205-217-30)
  • ndc11
    7120521760
    60 CAPSULE in 1 BOTTLE (71205-217-60)
  • ndc11
    7120521790
    90 CAPSULE in 1 BOTTLE (71205-217-90)

Annotations

UNII (FDA Substance ID)
11SV1951MR
TAMSULOSIN HYDROCHLORIDE
RxCUI 236495
Orange Book
A207405
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "11SV1951MR",
    "rxcui": "236495",
    "inchikey": "ZZIZZTHXZRDOFM-XFULWGLBSA-N",
    "display_name": "TAMSULOSIN HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "52bbe73b-43b6-3393-e063-6294a90a6dc6": {
      "match": "brand_token",
      "title": "TAMSULOSIN HYDROCHLORIDE CAPSULE [COUPLER LLC]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "71205-217_668d5539-1561-457c-9a7c-38784a9b5c66",
  "productndc": "71205-217",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "207405",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.4MG",
        "product_no": "001",
        "approval_date": "Aug 11, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TAMSULOSIN HYDROCHLORIDE",
  "proprietary_name": "Tamsulosin Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207405",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tamsulosin Hydrochloride",
  "start_marketing_date": "20170811",
  "active_numerator_strength": ".4"
}

Related drugs

Other records sharing ATC code G04CA02.

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