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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
- ndc116584169501100 CAPSULE in 1 BOTTLE (65841-695-01)
- ndc116584169505500 CAPSULE in 1 BOTTLE (65841-695-05)
- ndc11658416950630 CAPSULE in 1 BOTTLE (65841-695-06)
- ndc1165841695101000 CAPSULE in 1 BOTTLE (65841-695-10)
- ndc11658416951460 CAPSULE in 1 BOTTLE (65841-695-14)
- ndc11658416951690 CAPSULE in 1 BOTTLE (65841-695-16)
- ndc11658416957710 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
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