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United States · US · US:70954-151_1aa670cb-8d65-413a-9bdd-680cafd9b5c4

Naproxen Oral Suspension

Orange BookUNIISPLATC G02CC02

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

Identification

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

Packs · 1

  • ndc11
    7095415110
    500 mL in 1 BOTTLE (70954-151-10)

Annotations

UNII (FDA Substance ID)
57Y76R9ATQ
NAPROXEN
RxCUI 7258
Orange Book
A211910
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "57Y76R9ATQ",
    "rxcui": "7258",
    "inchikey": "CMWTZPSULFXXJA-VIFPVBQESA-N",
    "display_name": "NAPROXEN",
    "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": "70954-151_1aa670cb-8d65-413a-9bdd-680cafd9b5c4",
  "productndc": "70954-151",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "211910",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG/ML",
        "product_no": "001",
        "approval_date": "Mar 10, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NAPROXEN",
  "proprietary_name": "Naproxen Oral Suspension",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA211910",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen oral",
  "start_marketing_date": "20210312",
  "active_numerator_strength": "125"
}

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