Back to search
🇺🇸

United States · US · US:76420-787_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
    7642078701
    1 TABLET in 1 BOTTLE (76420-787-01)
  • ndc11
    7642078702
    2 TABLET in 1 BOTTLE (76420-787-02)
  • ndc11
    7642078705
    500 TABLET in 1 BOTTLE (76420-787-05)
  • ndc11
    7642078707
    7 TABLET in 1 BOTTLE (76420-787-07)
  • ndc11
    7642078710
    100 TABLET in 1 BOTTLE (76420-787-10)
  • ndc11
    7642078714
    14 TABLET in 1 BOTTLE (76420-787-14)
  • ndc11
    7642078720
    20 TABLET in 1 BOTTLE (76420-787-20)
  • ndc11
    7642078730
    30 TABLET in 1 BOTTLE (76420-787-30)
  • ndc11
    7642078760
    60 TABLET in 1 BOTTLE (76420-787-60)
  • ndc11
    7642078790
    90 TABLET in 1 BOTTLE (76420-787-90)

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": "76420-787_14060e9c-4605-5493-e063-6294a90ab6d3",
  "productndc": "76420-787",
  "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": "250"
}

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.