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United States · US · US:58602-816_554a4cb1-aaac-44f9-99c7-f342abdc3531

Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold

Orange BookUNIISPLATC G02CC

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

Identification

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

Packs · 3

  • ndc11
    5860281667
    2 BLISTER PACK in 1 CARTON (58602-816-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    5860281672
    3 BLISTER PACK in 1 CARTON (58602-816-72) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    5860281683
    1 BLISTER PACK in 1 CARTON (58602-816-83) / 10 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": "58602-816_554a4cb1-aaac-44f9-99c7-f342abdc3531",
  "productndc": "58602-816",
  "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 Sinus and Cold",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA211360",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen Sodium and Pseudoephedrine Hydrochloride",
  "start_marketing_date": "20220601",
  "active_numerator_strength": "220; 120"
}

Related drugs

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