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United States · US · US:71205-201_9143ab9f-5bc2-4ea6-a33b-01bbc1e880f0

Cyclobenzaprine Hydrochloride

Orange BookUNIISPLATC M03BX08

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeM03BX08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    7120520110
    10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-201-10)
  • ndc11
    7120520115
    15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-201-15)
  • ndc11
    7120520120
    20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-201-20)
  • ndc11
    7120520130
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-201-30)
  • ndc11
    7120520160
    60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-201-60)
  • ndc11
    7120520190
    90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-201-90)

Annotations

UNII (FDA Substance ID)
0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDE
RxCUI 52101
Orange Book
A077797
ABAB
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": "71205-201_9143ab9f-5bc2-4ea6-a33b-01bbc1e880f0",
  "productndc": "71205-201",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077797",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Feb 28, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Feb 28, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYCLOBENZAPRINE HYDROCHLORIDE",
  "proprietary_name": "Cyclobenzaprine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077797",
  "marketing_category": "ANDA",
  "nonproprietary_name": "cyclobenzaprine hydrochloride",
  "start_marketing_date": "20170330",
  "active_numerator_strength": "10"
}

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