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United States · US · US:71610-738_0df2d4c9-cc71-47ff-afb4-e2f49e551d75

Tamsulosin Hydrochloride

Orange BookUNIISPLATC G04CA02

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeG04CA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    7161073830
    30 CAPSULE in 1 BOTTLE (71610-738-30)
  • ndc11
    7161073853
    60 CAPSULE in 1 BOTTLE (71610-738-53)
  • ndc11
    7161073860
    90 CAPSULE in 1 BOTTLE (71610-738-60)
  • ndc11
    7161073870
    120 CAPSULE in 1 BOTTLE (71610-738-70)
  • ndc11
    7161073880
    180 CAPSULE in 1 BOTTLE (71610-738-80)

Annotations

UNII (FDA Substance ID)
11SV1951MR
TAMSULOSIN HYDROCHLORIDE
RxCUI 236495
Orange Book
A202433
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": "71610-738_0df2d4c9-cc71-47ff-afb4-e2f49e551d75",
  "productndc": "71610-738",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "202433",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.4MG",
        "product_no": "001",
        "approval_date": "Apr 30, 2013"
      }
    ],
    "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": "ANDA202433",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tamsulosin Hydrochloride",
  "start_marketing_date": "20130430",
  "active_numerator_strength": ".4"
}

Related drugs

Other records sharing ATC code G04CA02.

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