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United States · US · US:50090-5809_f22b7db7-372b-4cb8-a08f-7637e0fa46e0

Pravastatin Sodium

In shortageOrange BookUNIISPLATC C10AA03

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeC10AA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5009058090
    30 TABLET in 1 BOTTLE (50090-5809-0)
  • ndc11
    5009058091
    90 TABLET in 1 BOTTLE (50090-5809-1)

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": "50090-5809_f22b7db7-372b-4cb8-a08f-7637e0fa46e0",
  "productndc": "50090-5809",
  "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": "20071228",
  "active_numerator_strength": "80"
}

Related drugs

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