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United States · US · US:68462-196_a6e006b3-4256-4cbb-8ad1-b71f363430cd
Pravastatin Sodium
In shortageOrange BookUNIISPLATC C10AA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeC10AA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116846219605500 TABLET in 1 BOTTLE (68462-196-05)
- ndc11684621969090 TABLET in 1 BOTTLE (68462-196-90)
Annotations
UNII (FDA Substance ID)
3M8608UQ61
PRAVASTATIN SODIUM
RxCUI 203144
Orange Book
A077987
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": "68462-196_a6e006b3-4256-4cbb-8ad1-b71f363430cd",
"productndc": "68462-196",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "077987",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "May 11, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "May 11, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "40MG",
"product_no": "003",
"approval_date": "May 11, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "80MG",
"product_no": "004",
"approval_date": "Dec 28, 2007"
}
],
"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": "ANDA077987",
"marketing_category": "ANDA",
"nonproprietary_name": "Pravastatin Sodium",
"start_marketing_date": "20070511",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code C10AA03.
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