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United States · US · US:33342-159_95b0ff14-97b3-4b8c-8545-f066a45c2f82

Tamsulosin Hydrochloride

Orange BookUNIISPLATC G04CA02

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

Identification

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

Packs · 5

  • ndc11
    3334215907
    30 CAPSULE in 1 BOTTLE (33342-159-07)
  • ndc11
    3334215911
    100 CAPSULE in 1 BOTTLE (33342-159-11)
  • ndc11
    3334215912
    10 BLISTER PACK in 1 CARTON (33342-159-12) / 10 CAPSULE in 1 BLISTER PACK
  • ndc11
    3334215915
    500 CAPSULE in 1 BOTTLE (33342-159-15)
  • ndc11
    3334215944
    1000 CAPSULE in 1 BOTTLE (33342-159-44)

Annotations

UNII (FDA Substance ID)
11SV1951MR
TAMSULOSIN HYDROCHLORIDE
RxCUI 236495
Orange Book
A204645
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": "33342-159_95b0ff14-97b3-4b8c-8545-f066a45c2f82",
  "productndc": "33342-159",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "204645",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.4MG",
        "product_no": "001",
        "approval_date": "Jan 20, 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": "ANDA204645",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tamsulosin Hydrochloride",
  "start_marketing_date": "20170125",
  "active_numerator_strength": ".4"
}

Related drugs

Other records sharing ATC code G04CA02.

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