Naprelan

Orange BookUNIISPLATC G02CC02

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

Identification

ManufacturerAlmatica Pharma LLC

CountryUS (United States)

ATC codeG02CC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5242727201
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (52427-272-01)

Annotations

UNII (FDA Substance ID)

9TN87S3A3C

NAPROXEN SODIUM

RxCUI 142442

Orange Book

N020353

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "9TN87S3A3C",
    "rxcui": "142442",
    "inchikey": "CDBRNDSHEYLDJV-FVGYRXGTSA-M",
    "display_name": "NAPROXEN SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b8a51c9a-488e-4377-a041-436f6a2f8893": {
      "match": "brand_token",
      "title": "NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, LLC]",
      "spl_version": "2",
      "published_date": "2026-01-09"
    }
  },
  "productid": "52427-272_cc98185d-7e2e-eea6-8bbd-08585361b654",
  "productndc": "52427-272",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "020353",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 375MG BASE",
        "product_no": "001",
        "approval_date": "Jan 5, 1996"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "002",
        "approval_date": "Jan 5, 1996"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 750MG BASE",
        "product_no": "003",
        "approval_date": "Jan 5, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NAPROXEN SODIUM",
  "proprietary_name": "Naprelan",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020353",
  "marketing_category": "NDA",
  "nonproprietary_name": "Naproxen Sodium",
  "start_marketing_date": "20140117",
  "active_numerator_strength": "375"
}

Related drugs

Other records sharing ATC code G02CC02.

Access this data programmatically

Query Naprelan and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs