Back to search
🇺🇸

United States · US · US:76420-788_14060e9c-4605-5493-e063-6294a90ab6d3

Naproxen

Orange BookUNIISPLATC G02CC02

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

Identification

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

Packs · 10

  • ndc11
    7642078801
    1 TABLET in 1 BOTTLE (76420-788-01)
  • ndc11
    7642078802
    2 TABLET in 1 BOTTLE (76420-788-02)
  • ndc11
    7642078805
    500 TABLET in 1 BOTTLE (76420-788-05)
  • ndc11
    7642078807
    7 TABLET in 1 BOTTLE (76420-788-07)
  • ndc11
    7642078810
    100 TABLET in 1 BOTTLE (76420-788-10)
  • ndc11
    7642078814
    14 TABLET in 1 BOTTLE (76420-788-14)
  • ndc11
    7642078820
    20 TABLET in 1 BOTTLE (76420-788-20)
  • ndc11
    7642078830
    30 TABLET in 1 BOTTLE (76420-788-30)
  • ndc11
    7642078860
    60 TABLET in 1 BOTTLE (76420-788-60)
  • ndc11
    7642078890
    90 TABLET in 1 BOTTLE (76420-788-90)

Annotations

UNII (FDA Substance ID)
57Y76R9ATQ
NAPROXEN
RxCUI 7258
Orange Book
A212517
ABABAB
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": "76420-788_14060e9c-4605-5493-e063-6294a90ab6d3",
  "productndc": "76420-788",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "212517",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Feb 21, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "375MG",
        "product_no": "002",
        "approval_date": "Feb 21, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "003",
        "approval_date": "Feb 21, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NAPROXEN",
  "proprietary_name": "Naproxen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212517",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen",
  "start_marketing_date": "20200301",
  "active_numerator_strength": "375"
}

Related drugs

Other records sharing ATC code G02CC02.

Access this data programmatically

Query Naproxen and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.