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United States · US · US:0781-2076_98c2abd9-1998-48cd-83f9-f5f94ff39345

tamsulosin hydrochloride

Orange BookUNIISPLATC G04CA02

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

Identification

ManufacturerSandoz Inc
CountryUS (United States)
ATC codeG04CA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0781207601
    100 CAPSULE in 1 BOTTLE (0781-2076-01)
  • ndc11
    0781207610
    1000 CAPSULE in 1 BOTTLE (0781-2076-10)
  • ndc11
    0781207692
    90 CAPSULE in 1 BOTTLE (0781-2076-92)

Annotations

UNII (FDA Substance ID)
11SV1951MR
TAMSULOSIN HYDROCHLORIDE
RxCUI 236495
Orange Book
A078015
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": "0781-2076_98c2abd9-1998-48cd-83f9-f5f94ff39345",
  "productndc": "0781-2076",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "078015",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.4MG",
        "product_no": "001",
        "approval_date": "Apr 27, 2010"
      }
    ],
    "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": "ANDA078015",
  "marketing_category": "ANDA",
  "nonproprietary_name": "tamsulosin hydrochloride",
  "start_marketing_date": "20100427",
  "active_numerator_strength": ".4"
}

Related drugs

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