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United States · US · US:63629-4346_660d7436-8f1d-466b-b8d5-c67e5e2cdfe7

Tamsulosin Hydrochloride

Orange BookUNIISPLATC G04CA02

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeG04CA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 9

  • ndc11
    6362943461
    30 CAPSULE in 1 BOTTLE (63629-4346-1)
  • ndc11
    6362943462
    100 CAPSULE in 1 BOTTLE (63629-4346-2)
  • ndc11
    6362943463
    60 CAPSULE in 1 BOTTLE (63629-4346-3)
  • ndc11
    6362943464
    10 CAPSULE in 1 BOTTLE (63629-4346-4)
  • ndc11
    6362943465
    90 CAPSULE in 1 BOTTLE (63629-4346-5)
  • ndc11
    6362943466
    180 CAPSULE in 1 BOTTLE (63629-4346-6)
  • ndc11
    6362943467
    7 CAPSULE in 1 BOTTLE (63629-4346-7)
  • ndc11
    6362943468
    15 CAPSULE in 1 BOTTLE (63629-4346-8)
  • ndc11
    6362943469
    120 CAPSULE in 1 BOTTLE (63629-4346-9)

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": "63629-4346_660d7436-8f1d-466b-b8d5-c67e5e2cdfe7",
  "productndc": "63629-4346",
  "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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