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United States · US · US:62756-160_52595417-3e2e-4d58-9167-dd5b2bf1b082

Tamsulosin Hydrochloride

Orange BookUNIISPLATC G04CA02

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeG04CA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    6275616008
    100 CAPSULE in 1 BOTTLE (62756-160-08)
  • ndc11
    6275616013
    500 CAPSULE in 1 BOTTLE (62756-160-13)
  • ndc11
    6275616018
    1000 CAPSULE in 1 BOTTLE (62756-160-18)
  • ndc11
    6275616081
    90 CAPSULE in 1 BOTTLE (62756-160-81)
  • ndc11
    6275616083
    30 CAPSULE in 1 BOTTLE (62756-160-83)
  • ndc11
    6275616088
    100 CAPSULE in 1 BOTTLE (62756-160-88)

Annotations

UNII (FDA Substance ID)
11SV1951MR
TAMSULOSIN HYDROCHLORIDE
RxCUI 236495
Orange Book
A090931
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": "62756-160_52595417-3e2e-4d58-9167-dd5b2bf1b082",
  "productndc": "62756-160",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "090931",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.4MG",
        "product_no": "001",
        "approval_date": "Jul 15, 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": "ANDA090931",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tamsulosin Hydrochloride",
  "start_marketing_date": "20100715",
  "active_numerator_strength": ".4"
}

Related drugs

Other records sharing ATC code G04CA02.

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