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United States · US · US:62207-761_f4026a0a-c9cd-3850-e053-2995a90a459c

Naproxen Sodium

Orange BookUNIISPLATC G02CC02

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

Identification

ManufacturerGranules India Ltd
CountryUS (United States)
ATC codeG02CC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6220776142
    50 TABLET, FILM COATED in 1 BOTTLE (62207-761-42)
  • ndc11
    6220776143
    100 TABLET, FILM COATED in 1 BOTTLE (62207-761-43)
  • ndc11
    6220776147
    500 TABLET, FILM COATED in 1 BOTTLE (62207-761-47)
  • ndc11
    6220776149
    1000 TABLET, FILM COATED in 1 BOTTLE (62207-761-49)

Annotations

UNII (FDA Substance ID)
9TN87S3A3C
NAPROXEN SODIUM
RxCUI 142442
Orange Book
A091353
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": "62207-761_f4026a0a-c9cd-3850-e053-2995a90a459c",
  "productndc": "62207-761",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "091353",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "220MG",
        "product_no": "001",
        "approval_date": "Sep 20, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NAPROXEN SODIUM",
  "proprietary_name": "Naproxen Sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091353",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen Sodium",
  "start_marketing_date": "20110930",
  "active_numerator_strength": "220"
}

Related drugs

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