RELAFEN DS

Orange BookUNIISPLATC M01AX01

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

Identification

ManufacturerCarwin Pharmaceutical Associates, LLC

CountryUS (United States)

ATC codeM01AX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
1537017010
100 TABLET in 1 BOTTLE, PLASTIC (15370-170-10)
ndc11
1537017030
30 TABLET in 1 BOTTLE, PLASTIC (15370-170-30)
ndc11
1537017060
60 TABLET in 1 BOTTLE, PLASTIC (15370-170-60)
ndc11
1537017099
1 BLISTER PACK in 1 CARTON (15370-170-99) / 2 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

LW0TIW155Z

NABUMETONE

RxCUI 31448

Orange Book

A203166

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "LW0TIW155Z",
    "rxcui": "31448",
    "inchikey": "BLXXJMDCKKHMKV-UHFFFAOYSA-N",
    "display_name": "NABUMETONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a9a0af85-6c43-4a2d-ba75-0be4ca64c931": {
      "match": "brand_token",
      "title": "RELAFEN DS (NABUMETONE) TABLET [CARWIN PHARMACEUTICAL ASSOCIATES, LLC]",
      "spl_version": "5",
      "published_date": "2024-01-10"
    }
  },
  "productid": "15370-170_48aa3640-1dd2-4693-9b0d-a99595b97a0e",
  "productndc": "15370-170",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "203166",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Aug 30, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "002",
        "approval_date": "Aug 30, 2019"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "1GM",
        "product_no": "003",
        "approval_date": "Aug 30, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NABUMETONE",
  "proprietary_name": "RELAFEN DS",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203166",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NABUMETONE",
  "start_marketing_date": "20190920",
  "active_numerator_strength": "1000"
}

Related drugs

Other records sharing ATC code M01AX01.

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