Back to search
🇺🇸

United States · US · US:70771-1118_8eab99e7-f5e0-4b8a-8cc6-2d90618ebf93

ZYPITAMAG

Orange BookUNIISPLATC C10AA08

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeC10AA08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    7077111180
    1000 TABLET, FILM COATED in 1 BOTTLE (70771-1118-0)
  • ndc11
    7077111181
    100 TABLET, FILM COATED in 1 BOTTLE (70771-1118-1)
  • ndc11
    7077111183
    30 TABLET, FILM COATED in 1 BOTTLE (70771-1118-3)
  • ndc11
    7077111184
    10 BLISTER PACK in 1 CARTON (70771-1118-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    7077111185
    500 TABLET, FILM COATED in 1 BOTTLE (70771-1118-5)
  • ndc11
    7077111187
    1 BLISTER PACK in 1 CARTON (70771-1118-7) / 7 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    7077111189
    90 TABLET, FILM COATED in 1 BOTTLE (70771-1118-9)

Annotations

UNII (FDA Substance ID)
M5681Q5F9P
PITAVASTATIN
RxCUI 861634
Orange Book
N208379
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "M5681Q5F9P",
    "rxcui": "861634",
    "inchikey": "VGYFMXBACGZSIL-MCBHFWOFSA-N",
    "display_name": "PITAVASTATIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c8c50e03-5cb8-43f4-bdef-8edd12f1945f": {
      "match": "brand_token",
      "title": "ZYPITAMAG (PITAVASTATIN MAGNESIUM) TABLET, FILM COATED [MEDICURE INTERNATIONAL INC]",
      "spl_version": "14",
      "published_date": "2025-12-04"
    }
  },
  "productid": "70771-1118_8eab99e7-f5e0-4b8a-8cc6-2d90618ebf93",
  "productndc": "70771-1118",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208379",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Jul 14, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Jul 14, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "003",
        "approval_date": "Jul 14, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PITAVASTATIN",
  "proprietary_name": "ZYPITAMAG",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA208379",
  "marketing_category": "NDA",
  "nonproprietary_name": "Pitavastatin Magnesium",
  "start_marketing_date": "20180309",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code C10AA08.

Access this data programmatically

Query ZYPITAMAG 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.