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United States · US · US:16729-010_438f9112-0851-75e1-e063-6294a90a675c

PRAVASTATIN SODIUM

In shortageOrange BookUNIISPLATC C10AA03

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

Identification

ManufacturerAccord Healthcare Inc.
CountryUS (United States)
ATC codeC10AA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    1672901015
    90 TABLET in 1 BOTTLE (16729-010-15)
  • ndc11
    1672901016
    500 TABLET in 1 BOTTLE (16729-010-16)
  • ndc11
    1672901017
    1000 TABLET in 1 BOTTLE (16729-010-17)

Annotations

UNII (FDA Substance ID)
3M8608UQ61
PRAVASTATIN SODIUM
RxCUI 203144
Orange Book
A207068
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": "16729-010_438f9112-0851-75e1-e063-6294a90a675c",
  "productndc": "16729-010",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207068",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Nov 17, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Nov 17, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "003",
        "approval_date": "Nov 17, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "004",
        "approval_date": "Nov 17, 2016"
      }
    ],
    "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": "ANDA207068",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PRAVASTATIN SODIUM",
  "start_marketing_date": "20170216",
  "active_numerator_strength": "40"
}

Related drugs

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