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United States · US · US:50268-412_47e560c6-bd1f-1264-e063-6394a90a0048
HYDROXYCHLOROQUINE SULFATE
In shortageOrange BookUNIISPLATC P01BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvPAK
CountryUS (United States)
ATC codeP01BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11502684121550 BLISTER PACK in 1 BOX (50268-412-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-412-11)
Annotations
UNII (FDA Substance ID)
8Q2869CNVH
HYDROXYCHLOROQUINE SULFATE
RxCUI 153972
Orange Book
A210441
ABABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Hydroxychloroquine Sulfate Tablet
Raw payload (JSON)
{
"unii": {
"unii": "8Q2869CNVH",
"rxcui": "153972",
"inchikey": "JCBIVZZPXRZKTI-UHFFFAOYSA-N",
"display_name": "HYDROXYCHLOROQUINE SULFATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"6971241c-8323-456e-91a4-a404a9e100de": {
"match": "brand_token",
"title": "HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]",
"spl_version": "16",
"published_date": "2026-06-01"
}
},
"productid": "50268-412_47e560c6-bd1f-1264-e063-6394a90a0048",
"productndc": "50268-412",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "210441",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "May 1, 2018"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "002",
"approval_date": "Sep 19, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "003",
"approval_date": "Sep 19, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "004",
"approval_date": "Sep 19, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROXYCHLOROQUINE SULFATE",
"shortage_reason": "Hydroxychloroquine Sulfate Tablet",
"shortage_status": "current",
"proprietary_name": "HYDROXYCHLOROQUINE SULFATE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210441",
"marketing_category": "ANDA",
"nonproprietary_name": "HYDROXYCHLOROQUINE SULFATE",
"start_marketing_date": "20200515",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code P01BA02.
- CAAPO-HYDROXYQUINEAPOTEX INC
- PLAutokilaTarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.
- FIErcoquinOrion Pharma A/S
- 🇪🇸HIDROXICLOROQUINA ACCORD 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGAccord Healthcare S.L.U.
- 🇪🇸HIDROXICLOROQUINA ALDO-UNION 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGLaboratorio Aldo Union S.L.
- 🇪🇸HIDROXICLOROQUINA ARISTO 200 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFGAristo Pharma Gmbh
- 🇪🇸HIDROXICLOROQUINA AUROVITAS 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGAurovitas Spain, S.A.U.
- 🇪🇸HIDROXICLOROQUINA RUBIO 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGLaboratorios Rubio S.A.
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