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United States · US · US:70518-2052_519fedf6-cddd-0bf1-e063-6394a90a607a

Tamsulosin Hydrochloride

Orange BookUNIISPLATC G04CA02

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

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeG04CA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    7051820520
    90 CAPSULE in 1 BOTTLE, PLASTIC (70518-2052-0)
  • ndc11
    7051820521
    30 CAPSULE in 1 BLISTER PACK (70518-2052-1)
  • ndc11
    7051820523
    30 CAPSULE in 1 BOTTLE, PLASTIC (70518-2052-3)
  • ndc11
    7051820524
    14 CAPSULE in 1 BOTTLE, PLASTIC (70518-2052-4)
  • ndc11
    7051820525
    50 POUCH in 1 BOX (70518-2052-5) / 1 CAPSULE in 1 POUCH (70518-2052-6)

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": "70518-2052_519fedf6-cddd-0bf1-e063-6394a90a607a",
  "productndc": "70518-2052",
  "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": "20190430",
  "active_numerator_strength": ".4"
}

Related drugs

Other records sharing ATC code G04CA02.

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