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
7133519581
20 TABLET, FILM COATED in 1 BOTTLE (71335-1958-1)
ndc11
7133519582
14 TABLET, FILM COATED in 1 BOTTLE (71335-1958-2)
ndc11
7133519583
30 TABLET, FILM COATED in 1 BOTTLE (71335-1958-3)
ndc11
7133519584
100 TABLET, FILM COATED in 1 BOTTLE (71335-1958-4)
ndc11
7133519585
60 TABLET, FILM COATED in 1 BOTTLE (71335-1958-5)
ndc11
7133519586
90 TABLET, FILM COATED in 1 BOTTLE (71335-1958-6)
ndc11
7133519587
56 TABLET, FILM COATED in 1 BOTTLE (71335-1958-7)
ndc11
7133519588
120 TABLET, FILM COATED in 1 BOTTLE (71335-1958-8)

Annotations

UNII (FDA Substance ID)

2M36281008

ETODOLAC

RxCUI 24605

Orange Book

A075074

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": "71335-1958_45dc5310-0271-4d79-bfe3-5a4dcf71c6ea",
  "productndc": "71335-1958",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "075074",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Mar 11, 1998"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Apr 25, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETODOLAC",
  "proprietary_name": "Etodolac",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075074",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Etodolac",
  "start_marketing_date": "19980311",
  "active_numerator_strength": "400"
}

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