Naproxen Sodium

Orange BookUNIISPLATC G02CC02

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeG02CC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7120547915
15 TABLET, FILM COATED in 1 BOTTLE (71205-479-15)
ndc11
7120547930
30 TABLET, FILM COATED in 1 BOTTLE (71205-479-30)
ndc11
7120547960
60 TABLET, FILM COATED in 1 BOTTLE (71205-479-60)
ndc11
7120547990
90 TABLET, FILM COATED in 1 BOTTLE (71205-479-90)

Annotations

UNII (FDA Substance ID)

9TN87S3A3C

NAPROXEN SODIUM

RxCUI 142442

Orange Book

A200629

ABAB

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": {
    "c5146d73-2f34-4dfe-ac29-97071279dc4d": {
      "match": "brand_token",
      "title": "NAPROXEN SODIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "10",
      "published_date": "2026-05-28"
    }
  },
  "productid": "71205-479_397db794-027c-4a89-993e-07c208b457a3",
  "productndc": "71205-479",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "200629",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Oct 31, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "002",
        "approval_date": "Oct 31, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NAPROXEN SODIUM",
  "proprietary_name": "Naproxen Sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA200629",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen Sodium",
  "start_marketing_date": "20111031",
  "active_numerator_strength": "550"
}

Related drugs

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