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United States · US · US:68382-273_8ceb01d9-ccec-4c22-b56b-563af9da274f

Etodolac

Orange BookUNIISPLATC M01AB08

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeM01AB08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    6838227301
    100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-273-01)
  • ndc11
    6838227305
    500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-273-05)
  • ndc11
    6838227310
    1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-273-10)
  • ndc11
    6838227314
    60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-273-14)
  • ndc11
    6838227377
    100 BLISTER PACK in 1 CARTON (68382-273-77) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-273-30)

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": "68382-273_8ceb01d9-ccec-4c22-b56b-563af9da274f",
  "productndc": "68382-273",
  "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": "600"
}

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