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United States · US · US:65841-695_b05d1829-8334-4145-b49d-6074624bc499

Tamsulosin Hydrochloride

Orange BookUNIISPLATC G04CA02

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeG04CA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    6584169501
    100 CAPSULE in 1 BOTTLE (65841-695-01)
  • ndc11
    6584169505
    500 CAPSULE in 1 BOTTLE (65841-695-05)
  • ndc11
    6584169506
    30 CAPSULE in 1 BOTTLE (65841-695-06)
  • ndc11
    6584169510
    1000 CAPSULE in 1 BOTTLE (65841-695-10)
  • ndc11
    6584169514
    60 CAPSULE in 1 BOTTLE (65841-695-14)
  • ndc11
    6584169516
    90 CAPSULE in 1 BOTTLE (65841-695-16)
  • ndc11
    6584169577
    10 BLISTER PACK in 1 CARTON (65841-695-77) / 10 CAPSULE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
11SV1951MR
TAMSULOSIN HYDROCHLORIDE
RxCUI 236495
Orange Book
A078225
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": "65841-695_b05d1829-8334-4145-b49d-6074624bc499",
  "productndc": "65841-695",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "078225",
    "products": [
      {
        "rs": true,
        "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": "ANDA078225",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tamsulosin Hydrochloride",
  "start_marketing_date": "20100427",
  "active_numerator_strength": ".4"
}

Related drugs

Other records sharing ATC code G04CA02.

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