Etodolac

Orange BookUNIISPLATC M01AB08

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

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
6838227101
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-271-01)
ndc11
6838227105
500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-271-05)
ndc11
6838227110
1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-271-10)
ndc11
6838227114
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-271-14)
ndc11
6838227177
100 BLISTER PACK in 1 CARTON (68382-271-77) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-271-30)

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": "68382-271_8ceb01d9-ccec-4c22-b56b-563af9da274f",
  "productndc": "68382-271",
  "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": "400"
}

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