Etodolac

Orange BookUNIISPLATC M01AB08

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeM01AB08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6318737430
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-374-30)
ndc11
6318737460
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-374-60)
ndc11
6318737490
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-374-90)

Annotations

UNII (FDA Substance ID)

2M36281008

ETODOLAC

RxCUI 24605

Orange Book

A091134

ABABAB

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": "63187-374_dd9d2003-9288-4d96-8910-705710883378",
  "productndc": "63187-374",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "091134",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Jan 23, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Jan 23, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "003",
        "approval_date": "Jan 23, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETODOLAC",
  "proprietary_name": "Etodolac",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091134",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Etodolac",
  "start_marketing_date": "20140215",
  "active_numerator_strength": "400"
}

Related drugs

Other records sharing ATC code M01AB08.

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