Pravastatin sodium

In shortageOrange BookUNIISPLATC C10AA03

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

Identification

ManufacturerDr.Reddy's Laboratories Limited

CountryUS (United States)

ATC codeC10AA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
5511123101
100 TABLET in 1 BOTTLE (55111-231-01)
ndc11
5511123105
500 TABLET in 1 BOTTLE (55111-231-05)
ndc11
5511123130
30 TABLET in 1 BOTTLE (55111-231-30)
ndc11
5511123190
90 TABLET in 1 BOTTLE (55111-231-90)

Annotations

UNII (FDA Substance ID)

3M8608UQ61

PRAVASTATIN SODIUM

RxCUI 203144

Orange Book

A076714

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": "55111-231_5f4e21ff-4bcc-df0d-a629-ba190d95edc0",
  "productndc": "55111-231",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076714",
    "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": "ANDA076714",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pravastatin sodium",
  "start_marketing_date": "20091231",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code C10AA03.

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