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United States · US · US:71179-816_ed5a625e-a3a7-4d6a-83fd-78de2a2473b8

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE COLD AND SINUS

Orange BookUNIISPLATC G02CC

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

Identification

ManufacturerVESPYR BRANDS LLC
CountryUS (United States)
ATC codeG02CC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7117981624
    3 BLISTER PACK in 1 CARTON (71179-816-24) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
9TN87S3A3C
NAPROXEN SODIUM
RxCUI 142442
Orange Book
A211360
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": "71179-816_ed5a625e-a3a7-4d6a-83fd-78de2a2473b8",
  "productndc": "71179-816",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "211360",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "220MG;120MG",
        "product_no": "001",
        "approval_date": "Jun 1, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE COLD AND SINUS",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA211360",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen Sodium and Pseudoephedrine Hydrochloride",
  "start_marketing_date": "20240807",
  "active_numerator_strength": "220; 120"
}

Related drugs

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