Etodolac

Orange BookUNIISPLATC M01AB08

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.

CountryUS (United States)

ATC codeM01AB08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6878888461
100 TABLET, FILM COATED in 1 BOTTLE (68788-8846-1)
ndc11
6878888462
20 TABLET, FILM COATED in 1 BOTTLE (68788-8846-2)
ndc11
6878888463
30 TABLET, FILM COATED in 1 BOTTLE (68788-8846-3)
ndc11
6878888466
60 TABLET, FILM COATED in 1 BOTTLE (68788-8846-6)
ndc11
6878888469
90 TABLET, FILM COATED in 1 BOTTLE (68788-8846-9)

Annotations

UNII (FDA Substance ID)

2M36281008

ETODOLAC

RxCUI 24605

Orange Book

A076004

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "2M36281008",
    "rxcui": "24605",
    "inchikey": "NNYBQONXHNTVIJ-UHFFFAOYSA-N",
    "display_name": "ETODOLAC",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "007c55fa-ef8b-4a8e-bfe5-e47c6e5da727": {
      "match": "brand_token",
      "title": "ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "26",
      "published_date": "2026-05-25"
    }
  },
  "productid": "68788-8846_556a7d5f-2c3c-4efb-ac0c-fca140791602",
  "productndc": "68788-8846",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "076004",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Dec 3, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Dec 3, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETODOLAC",
  "proprietary_name": "Etodolac",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076004",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Etodolac",
  "start_marketing_date": "20250324",
  "active_numerator_strength": "400"
}

Related drugs

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