PRAVASTATIN SODIUM

In shortageOrange BookUNIISPLATC C10AA03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeC10AA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7278914330
30 TABLET in 1 BOTTLE, PLASTIC (72789-143-30)

Annotations

UNII (FDA Substance ID)

3M8608UQ61

PRAVASTATIN SODIUM

RxCUI 203144

Orange Book

A076341

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": "72789-143_2d686029-d11c-3f24-e063-6394a90aae0c",
  "productndc": "72789-143",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076341",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Oct 23, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Oct 23, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "003",
        "approval_date": "Oct 23, 2006"
      },
      {
        "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": "ANDA076341",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PRAVASTATIN SODIUM",
  "start_marketing_date": "20110718",
  "active_numerator_strength": "20"
}

Related drugs

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