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United States · US · US:68788-7050_574eb543-d5c6-4d15-a63c-7207e9d11745
Tamsulosin Hydrochloride
Orange BookUNIISPLATC G04CA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG04CA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc116878870501100 CAPSULE in 1 BOTTLE (68788-7050-1)
- ndc11687887050220 CAPSULE in 1 BOTTLE (68788-7050-2)
- ndc11687887050330 CAPSULE in 1 BOTTLE (68788-7050-3)
- ndc11687887050660 CAPSULE in 1 BOTTLE (68788-7050-6)
- ndc116878870508120 CAPSULE in 1 BOTTLE (68788-7050-8)
- ndc11687887050990 CAPSULE in 1 BOTTLE (68788-7050-9)
Annotations
UNII (FDA Substance ID)
11SV1951MR
TAMSULOSIN HYDROCHLORIDE
RxCUI 236495
Orange Book
A202433
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": "68788-7050_574eb543-d5c6-4d15-a63c-7207e9d11745",
"productndc": "68788-7050",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "202433",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.4MG",
"product_no": "001",
"approval_date": "Apr 30, 2013"
}
],
"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": "ANDA202433",
"marketing_category": "ANDA",
"nonproprietary_name": "Tamsulosin Hydrochloride",
"start_marketing_date": "20200601",
"active_numerator_strength": ".4"
}Related drugs
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