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United States · US · US:70518-4339_4030e199-7260-81fc-e063-6394a90a315b
Pravastatin sodium
In shortageOrange BookUNIISPLATC C10AA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeC10AA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11705184339030 TABLET in 1 BLISTER PACK (70518-4339-0)
- ndc11705184339190 TABLET in 1 BOTTLE, PLASTIC (70518-4339-1)
Annotations
UNII (FDA Substance ID)
3M8608UQ61
PRAVASTATIN SODIUM
RxCUI 203144
Orange Book
A076056
ABABAB
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": "70518-4339_4030e199-7260-81fc-e063-6394a90a315b",
"productndc": "70518-4339",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076056",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Apr 24, 2006"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Apr 24, 2006"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "003",
"approval_date": "Apr 24, 2006"
}
],
"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": "ANDA076056",
"marketing_category": "ANDA",
"nonproprietary_name": "Pravastatin sodium",
"start_marketing_date": "20250513",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code C10AA03.
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