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United States · US · US:84386-034_c21d4797-d252-4073-891f-330484c5f643
Pravastatin sodium
In shortageOrange BookUNIISPLATC C10AA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeC10AA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11843860349090 TABLET in 1 BOTTLE (84386-034-90)
- ndc1184386034991000 TABLET in 1 BOTTLE (84386-034-99)
Annotations
UNII (FDA Substance ID)
3M8608UQ61
PRAVASTATIN SODIUM
RxCUI 203144
Orange Book
A077793
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Pravastatin Sodium Tablet
Raw payload (JSON)
{
"unii": {
"unii": "3M8608UQ61",
"rxcui": "203144",
"inchikey": "VWBQYTRBTXKKOG-IYNICTALSA-M",
"display_name": "PRAVASTATIN SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"dcf46d0c-87da-4009-b238-eb5cf287c3ed": {
"match": "brand_token",
"title": "PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]",
"spl_version": "104",
"published_date": "2026-06-01"
}
},
"productid": "84386-034_c21d4797-d252-4073-891f-330484c5f643",
"productndc": "84386-034",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "077793",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "80MG",
"product_no": "001",
"approval_date": "Jan 15, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PRAVASTATIN SODIUM",
"shortage_reason": "Pravastatin Sodium Tablet",
"shortage_status": "current",
"proprietary_name": "Pravastatin sodium",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077793",
"marketing_category": "ANDA",
"nonproprietary_name": "Pravastatin sodium",
"start_marketing_date": "20250227",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code C10AA03.
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