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United States · US · US:68788-7800_e522f024-b4ac-4ff4-8368-e9e6da9eb37e

Naproxen Sodium

Orange BookUNIISPLATC G02CC02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPreferred Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG02CC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    6878878001
    100 TABLET in 1 BOTTLE (68788-7800-1)
  • ndc11
    6878878002
    20 TABLET in 1 BOTTLE (68788-7800-2)
  • ndc11
    6878878003
    30 TABLET in 1 BOTTLE (68788-7800-3)
  • ndc11
    6878878004
    14 TABLET in 1 BOTTLE (68788-7800-4)
  • ndc11
    6878878006
    60 TABLET in 1 BOTTLE (68788-7800-6)
  • ndc11
    6878878008
    120 TABLET in 1 BOTTLE (68788-7800-8)
  • ndc11
    6878878009
    90 TABLET in 1 BOTTLE (68788-7800-9)

Annotations

UNII (FDA Substance ID)
9TN87S3A3C
NAPROXEN SODIUM
RxCUI 142442
Orange Book
A212199
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": "68788-7800_e522f024-b4ac-4ff4-8368-e9e6da9eb37e",
  "productndc": "68788-7800",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "212199",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Oct 30, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "002",
        "approval_date": "Oct 30, 2019"
      }
    ],
    "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": "ANDA212199",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen Sodium",
  "start_marketing_date": "20201013",
  "active_numerator_strength": "550"
}

Related drugs

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