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 · 8

ndc11
7133522591
20 TABLET, FILM COATED in 1 BOTTLE (71335-2259-1)
ndc11
7133522592
14 TABLET, FILM COATED in 1 BOTTLE (71335-2259-2)
ndc11
7133522593
30 TABLET, FILM COATED in 1 BOTTLE (71335-2259-3)
ndc11
7133522594
100 TABLET, FILM COATED in 1 BOTTLE (71335-2259-4)
ndc11
7133522595
60 TABLET, FILM COATED in 1 BOTTLE (71335-2259-5)
ndc11
7133522596
90 TABLET, FILM COATED in 1 BOTTLE (71335-2259-6)
ndc11
7133522597
56 TABLET, FILM COATED in 1 BOTTLE (71335-2259-7)
ndc11
7133522598
120 TABLET, FILM COATED in 1 BOTTLE (71335-2259-8)

Annotations

UNII (FDA Substance ID)

2M36281008

ETODOLAC

RxCUI 24605

Orange Book

A210704

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": "71335-2259_2b889026-2eb9-4894-a68d-2fcf5a3ceae4",
  "productndc": "71335-2259",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "210704",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Dec 16, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Dec 16, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETODOLAC",
  "proprietary_name": "Etodolac",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210704",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Etodolac",
  "start_marketing_date": "20210801",
  "active_numerator_strength": "400"
}

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