Naproxen sodium

Orange BookUNIISPLATC G02CC02

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

Identification

ManufacturerDr. Reddy's Laboratories Inc.

CountryUS (United States)

ATC codeG02CC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
4359849401
100 TABLET, FILM COATED in 1 BOTTLE (43598-494-01)
ndc11
4359849405
500 TABLET, FILM COATED in 1 BOTTLE (43598-494-05)
ndc11
4359849410
1000 TABLET, FILM COATED in 1 BOTTLE (43598-494-10)
ndc11
4359849430
30 TABLET, FILM COATED in 1 BOTTLE (43598-494-30)

Annotations

UNII (FDA Substance ID)

9TN87S3A3C

NAPROXEN SODIUM

RxCUI 142442

Orange Book

A078486

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": "43598-494_3498dec1-32e7-ecde-c86e-4c1d7cb0b080",
  "productndc": "43598-494",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078486",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Jul 26, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "002",
        "approval_date": "Jul 26, 2007"
      }
    ],
    "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": "ANDA078486",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen sodium",
  "start_marketing_date": "20160426",
  "active_numerator_strength": "275"
}

Related drugs

Other records sharing ATC code G02CC02.

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