Etodolac

Orange BookUNIISPLATC M01AB08

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeM01AB08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
7133503991
60 TABLET, FILM COATED in 1 BOTTLE (71335-0399-1)
ndc11
7133503992
90 TABLET, FILM COATED in 1 BOTTLE (71335-0399-2)
ndc11
7133503993
30 TABLET, FILM COATED in 1 BOTTLE (71335-0399-3)
ndc11
7133503994
100 TABLET, FILM COATED in 1 BOTTLE (71335-0399-4)
ndc11
7133503995
6 TABLET, FILM COATED in 1 BOTTLE (71335-0399-5)
ndc11
7133503996
20 TABLET, FILM COATED in 1 BOTTLE (71335-0399-6)
ndc11
7133503997
14 TABLET, FILM COATED in 1 BOTTLE (71335-0399-7)

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": "71335-0399_51096aec-e133-4461-94c1-d591a81b3df7",
  "productndc": "71335-0399",
  "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": "20030501",
  "active_numerator_strength": "500"
}

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