Naproxen sodium

Orange BookUNIISPLATC G02CC02

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeG02CC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
7133516500
6 TABLET, FILM COATED in 1 BOTTLE (71335-1650-0)
ndc11
7133516501
20 TABLET, FILM COATED in 1 BOTTLE (71335-1650-1)
ndc11
7133516502
100 TABLET, FILM COATED in 1 BOTTLE (71335-1650-2)
ndc11
7133516503
30 TABLET, FILM COATED in 1 BOTTLE (71335-1650-3)
ndc11
7133516504
120 TABLET, FILM COATED in 1 BOTTLE (71335-1650-4)
ndc11
7133516505
60 TABLET, FILM COATED in 1 BOTTLE (71335-1650-5)
ndc11
7133516506
90 TABLET, FILM COATED in 1 BOTTLE (71335-1650-6)
ndc11
7133516507
42 TABLET, FILM COATED in 1 BOTTLE (71335-1650-7)
ndc11
7133516508
14 TABLET, FILM COATED in 1 BOTTLE (71335-1650-8)
ndc11
7133516509
56 TABLET, FILM COATED in 1 BOTTLE (71335-1650-9)

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": "71335-1650_2bd1f190-c76c-4003-9ab9-1c6c27dde97a",
  "productndc": "71335-1650",
  "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": "550"
}

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