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United States · US · US:0378-3000_4be1c27e-b52c-472c-8795-16af910fa26e

Meclofenamate Sodium

Orange BookUNIISPLATC M01AG04

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

Identification

ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeM01AG04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0378300001
    100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3000-01)

Annotations

UNII (FDA Substance ID)
94NJ818U2W
MECLOFENAMATE SODIUM
RxCUI 6677
Orange Book
A071081
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "94NJ818U2W",
    "rxcui": "6677",
    "inchikey": "QHJLLDJTVQAFAN-UHFFFAOYSA-M",
    "display_name": "MECLOFENAMATE SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "96f19af4-de8f-4fd7-90d8-55fe6ebdd81d": {
      "match": "brand_token",
      "title": "MECLOFENAMATE SODIUM CAPSULE [MYLAN PHARMACEUTICALS INC.]",
      "spl_version": "20",
      "published_date": "2026-05-29"
    }
  },
  "productid": "0378-3000_4be1c27e-b52c-472c-8795-16af910fa26e",
  "productndc": "0378-3000",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "071081",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Sep 3, 1986"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Sep 3, 1986"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MECLOFENAMATE SODIUM",
  "proprietary_name": "Meclofenamate Sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA071081",
  "marketing_category": "ANDA",
  "nonproprietary_name": "meclofenamate sodium",
  "start_marketing_date": "19860903",
  "active_numerator_strength": "100"
}

Related drugs

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