Back to search
🇺🇸

United States · US · US:68788-7660_e1e742f9-41dd-484b-acdb-7cabb84b8d6b

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 · 6

  • ndc11
    6878876600
    100 TABLET in 1 BOTTLE (68788-7660-0)
  • ndc11
    6878876602
    20 TABLET in 1 BOTTLE (68788-7660-2)
  • ndc11
    6878876603
    30 TABLET in 1 BOTTLE (68788-7660-3)
  • ndc11
    6878876606
    60 TABLET in 1 BOTTLE (68788-7660-6)
  • ndc11
    6878876608
    120 TABLET in 1 BOTTLE (68788-7660-8)
  • ndc11
    6878876609
    90 TABLET in 1 BOTTLE (68788-7660-9)

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": "68788-7660_e1e742f9-41dd-484b-acdb-7cabb84b8d6b",
  "productndc": "68788-7660",
  "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": "20220927",
  "active_numerator_strength": "80"
}

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.