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United States · US · US:63629-3641_36d35f56-5910-4774-8dab-8faca4101c5d

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
    6362936411
    60 CAPSULE in 1 BOTTLE (63629-3641-1)
  • ndc11
    6362936412
    90 CAPSULE in 1 BOTTLE (63629-3641-2)
  • ndc11
    6362936413
    18 CAPSULE in 1 BOTTLE (63629-3641-3)

Annotations

UNII (FDA Substance ID)
2M36281008
ETODOLAC
RxCUI 24605
Orange Book
A075126
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": "63629-3641_36d35f56-5910-4774-8dab-8faca4101c5d",
  "productndc": "63629-3641",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "075126",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Sep 16, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Sep 16, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETODOLAC",
  "proprietary_name": "Etodolac",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075126",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Etodolac",
  "start_marketing_date": "20150309",
  "active_numerator_strength": "200"
}

Related drugs

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