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United States · US · US:69292-104_52351ef8-7a5a-6e07-e063-6294a90af72a
Pravastatin Sodium
In shortageOrange BookUNIISPLATC C10AA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmici Pharma, Inc.
CountryUS (United States)
ATC codeC10AA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1169292104101000 TABLET in 1 BOTTLE (69292-104-10)
- ndc116929210450500 TABLET in 1 BOTTLE (69292-104-50)
- ndc11692921049090 TABLET in 1 BOTTLE (69292-104-90)
Annotations
UNII (FDA Substance ID)
3M8608UQ61
PRAVASTATIN SODIUM
RxCUI 203144
Orange Book
A077491
ABABABAB
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": "69292-104_52351ef8-7a5a-6e07-e063-6294a90af72a",
"productndc": "69292-104",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "077491",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "80MG",
"product_no": "001",
"approval_date": "Feb 11, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Oct 23, 2006"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "003",
"approval_date": "Oct 23, 2006"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "004",
"approval_date": "Oct 23, 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": "ANDA077491",
"marketing_category": "ANDA",
"nonproprietary_name": "Pravastatin Sodium",
"start_marketing_date": "20260519",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code C10AA03.
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