Pravastatin Sodium

In shortageOrange BookUNIISPLATC C10AA03

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

Identification

ManufacturerNorthwind Health Company, LLC

CountryUS (United States)

ATC codeC10AA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5165534352
30 TABLET in 1 BOTTLE, PLASTIC (51655-343-52)

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": "51655-343_48eb3563-bc9a-8be1-e063-6394a90a09b5",
  "productndc": "51655-343",
  "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": "20230228",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code C10AA03.

Access this data programmatically

Query Pravastatin Sodium and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs