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United States · US · US:68788-4059_f92e12bc-40c3-4afa-9190-2f4de11ec6b3

Pravastatin sodium

In shortageOrange BookUNIISPLATC C10AA03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC10AA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6878840593
    30 TABLET in 1 BOTTLE (68788-4059-3)
  • ndc11
    6878840596
    60 TABLET in 1 BOTTLE (68788-4059-6)
  • ndc11
    6878840599
    90 TABLET in 1 BOTTLE (68788-4059-9)

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": "68788-4059_f92e12bc-40c3-4afa-9190-2f4de11ec6b3",
  "productndc": "68788-4059",
  "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": "20251208",
  "active_numerator_strength": "10"
}

Related drugs

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