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United States · US · US:68382-132_ee9d9efd-0c79-4993-bfd7-d4c30e20bddd
Tamsulosin Hydrochloride
Orange BookUNIISPLATC G04CA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeG04CA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc116838213201100 CAPSULE in 1 BOTTLE (68382-132-01)
- ndc116838213205500 CAPSULE in 1 BOTTLE (68382-132-05)
- ndc11683821320630 CAPSULE in 1 BOTTLE (68382-132-06)
- ndc1168382132101000 CAPSULE in 1 BOTTLE (68382-132-10)
- ndc11683821321460 CAPSULE in 1 BOTTLE (68382-132-14)
- ndc11683821321690 CAPSULE in 1 BOTTLE (68382-132-16)
- ndc116838213277100 BLISTER PACK in 1 CARTON (68382-132-77) / 1 CAPSULE in 1 BLISTER PACK (68382-132-30)
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": "68382-132_ee9d9efd-0c79-4993-bfd7-d4c30e20bddd",
"productndc": "68382-132",
"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
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