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United States · US · US:71335-3119_24b80ca8-c835-44c1-b73a-d9a3d5ecd0fb

Etodolac

Orange BookUNIISPLATC M01AB08

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeM01AB08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7133531191
    60 CAPSULE in 1 BOTTLE (71335-3119-1)
  • ndc11
    7133531192
    90 CAPSULE in 1 BOTTLE (71335-3119-2)
  • ndc11
    7133531193
    18 CAPSULE in 1 BOTTLE (71335-3119-3)

Annotations

UNII (FDA Substance ID)
2M36281008
ETODOLAC
RxCUI 24605
Orange Book
A075078
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": "71335-3119_24b80ca8-c835-44c1-b73a-d9a3d5ecd0fb",
  "productndc": "71335-3119",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "075078",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Apr 30, 1998"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Apr 30, 1998"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETODOLAC",
  "proprietary_name": "Etodolac",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075078",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Etodolac",
  "start_marketing_date": "19980430",
  "active_numerator_strength": "200"
}

Related drugs

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