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United States · US · US:55758-048_4d7ad592-5b3b-e731-e063-6394a90a11e0

Rapidol Naproxen

Orange BookUNIISPLATC G02CC02

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

Identification

ManufacturerPharmadel LLC
CountryUS (United States)
ATC codeG02CC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5575804802
    2 TABLET, COATED in 1 PACKET (55758-048-02)
  • ndc11
    5575804824
    1 BOTTLE in 1 CARTON (55758-048-24) / 24 TABLET, COATED in 1 BOTTLE
  • ndc11
    5575804850
    25 PACKET in 1 CARTON (55758-048-50) / 2 TABLET, COATED in 1 PACKET (55758-048-02)

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": {
    "b4c9a653-6f51-7c98-e053-2995a90ada37": {
      "match": "brand_token",
      "title": "RAPIDOL SODIUM BICARBONATE (SODIUM BICARBONATE) POWDER [PHARMADEL LLC]",
      "spl_version": "4",
      "published_date": "2026-03-30"
    }
  },
  "productid": "55758-048_4d7ad592-5b3b-e731-e063-6394a90a11e0",
  "productndc": "55758-048",
  "dosage_form": "TABLET, 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": "Rapidol Naproxen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091353",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen sodium",
  "start_marketing_date": "20191009",
  "active_numerator_strength": "220"
}

Related drugs

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