🇺🇸
United States · US · US:43353-719_80c4cb36-638f-4d42-aa92-c5428ba5c547
Hydrochlorothiazide
In shortageOrange BookUNIISPLATC C03AX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeC03AX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 8
- ndc11433537191515 TABLET in 1 BOTTLE (43353-719-15)
- ndc11433537193030 TABLET in 1 BOTTLE (43353-719-30)
- ndc11433537194545 TABLET in 1 BOTTLE (43353-719-45)
- ndc11433537195360 TABLET in 1 BOTTLE (43353-719-53)
- ndc11433537196090 TABLET in 1 BOTTLE (43353-719-60)
- ndc114335371965100 TABLET in 1 BOTTLE (43353-719-65)
- ndc114335371973135 TABLET in 1 BOTTLE (43353-719-73)
- ndc114335371980180 TABLET in 1 BOTTLE (43353-719-80)
Annotations
UNII (FDA Substance ID)
0J48LPH2TH
HYDROCHLOROTHIAZIDE
RxCUI 5487
Orange Book
A083177
ABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Hydrochlorothiazide Capsule
Raw payload (JSON)
{
"unii": {
"unii": "0J48LPH2TH",
"rxcui": "5487",
"inchikey": "JZUFKLXOESDKRF-UHFFFAOYSA-N",
"display_name": "HYDROCHLOROTHIAZIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"a013211e-b8f8-426d-8e55-e86193f0634e": {
"match": "brand_token",
"title": "HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK]",
"spl_version": "9",
"published_date": "2026-05-21"
}
},
"productid": "43353-719_80c4cb36-638f-4d42-aa92-c5428ba5c547",
"productndc": "43353-719",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "083177",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "12.5MG",
"product_no": "003",
"approval_date": "Sep 19, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROCHLOROTHIAZIDE",
"shortage_reason": "Hydrochlorothiazide Capsule",
"shortage_status": "current",
"proprietary_name": "Hydrochlorothiazide",
"active_ingred_unit": "mg/1",
"application_number": "ANDA083177",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydrochlorothiazide",
"start_marketing_date": "19730112",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code C03AX01.
- 🇪🇸ESIDREX 25 mg COMPRIMIDOSLaboratoires Juvise Pharmaceuticals
- 🇫🇷ESIDREX 25 mg, comprimé sécableLABORATOIRES JUVISE PHARMACEUTICALS
- 🇪🇸HIDROCLOROTIAZIDA APOTEX 25 MG COMPRIMIDOS EFGApotex Europe B.V.
- 🇪🇸HIDROCLOROTIAZIDA APOTEX 50 MG COMPRIMIDOSApotex Europe B.V.
- 🇪🇸HIDROCLOROTIAZIDA ARISTO 25 MG COMPRIMIDOS EFGAristo Pharma Iberia S.L.
- 🇪🇸HIDROCLOROTIAZIDA AUROVITAS 25 MG COMPRIMIDOS EFGAurovitas Spain, S.A.U.
- 🇪🇸HIDROCLOROTIAZIDA AUROVITAS 50 MG COMPRIMIDOSAurovitas Spain, S.A.U.
- 🇪🇸HIDROCLOROTIAZIDA CINFA 12,5 MG COMPRIMIDOSLaboratorios Cinfa S.A.
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