etodolac

Orange BookUNIISPLATC M01AB08

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

Identification

ManufacturerIpca Laboratories Limited

CountryUS (United States)

ATC codeM01AB08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
8398003201
100 CAPSULE in 1 BOTTLE (83980-032-01)
ndc11
8398003205
500 CAPSULE in 1 BOTTLE (83980-032-05)
ndc11
8398003213
30 CAPSULE in 1 BOTTLE (83980-032-13)

Annotations

UNII (FDA Substance ID)

2M36281008

ETODOLAC

RxCUI 24605

Orange Book

A205448

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": "83980-032_fa34700b-9acd-4ccf-9e98-0f88e4a35e12",
  "productndc": "83980-032",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "205448",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Aug 1, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Aug 1, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETODOLAC",
  "proprietary_name": "etodolac",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205448",
  "marketing_category": "ANDA",
  "nonproprietary_name": "etodolac",
  "start_marketing_date": "20260206",
  "active_numerator_strength": "300"
}

Related drugs

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