Back to search
🇺🇸

United States · US · US:80425-0155_2a99a7c1-c4c1-2b01-e063-6294a90aa3b8

Cyclobenzaprine HCL

Orange BookUNIISPLATC M03BX08

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

Identification

ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC
CountryUS (United States)
ATC codeM03BX08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    8042501551
    30 TABLET, FILM COATED in 1 BOTTLE (80425-0155-1)
  • ndc11
    8042501552
    60 TABLET, FILM COATED in 1 BOTTLE (80425-0155-2)
  • ndc11
    8042501553
    90 TABLET, FILM COATED in 1 BOTTLE (80425-0155-3)
  • ndc11
    8042501554
    120 TABLET, FILM COATED in 1 BOTTLE (80425-0155-4)
  • ndc11
    8042501555
    180 TABLET, FILM COATED in 1 BOTTLE (80425-0155-5)

Annotations

UNII (FDA Substance ID)
0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDE
RxCUI 52101
Orange Book
A213324
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "0VE05JYS2P",
    "rxcui": "52101",
    "inchikey": "VXEAYBOGHINOKW-UHFFFAOYSA-N",
    "display_name": "CYCLOBENZAPRINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "fe81c68d-a579-4fe9-e053-6294a90a7bc0": {
      "match": "brand_token",
      "title": "CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]",
      "spl_version": "8",
      "published_date": "2026-06-01"
    }
  },
  "productid": "80425-0155_2a99a7c1-c4c1-2b01-e063-6294a90aa3b8",
  "productndc": "80425-0155",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "213324",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jul 6, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "002",
        "approval_date": "Jul 6, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Jul 5, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYCLOBENZAPRINE HYDROCHLORIDE",
  "proprietary_name": "Cyclobenzaprine HCL",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213324",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyclobenzaprine HCL",
  "start_marketing_date": "20200706",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code M03BX08.

Access this data programmatically

Query Cyclobenzaprine HCL 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.