CYCLOBENZAPRINE HYDROCHLORIDE

Orange BookUNIISPLATC M03BX08

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeM03BX08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
7120506510
10 TABLET, FILM COATED in 1 BOTTLE (71205-065-10)
ndc11
7120506512
12 TABLET, FILM COATED in 1 BOTTLE (71205-065-12)
ndc11
7120506515
15 TABLET, FILM COATED in 1 BOTTLE (71205-065-15)
ndc11
7120506520
20 TABLET, FILM COATED in 1 BOTTLE (71205-065-20)
ndc11
7120506521
21 TABLET, FILM COATED in 1 BOTTLE (71205-065-21)
ndc11
7120506530
30 TABLET, FILM COATED in 1 BOTTLE (71205-065-30)
ndc11
7120506545
45 TABLET, FILM COATED in 1 BOTTLE (71205-065-45)
ndc11
7120506560
60 TABLET, FILM COATED in 1 BOTTLE (71205-065-60)
ndc11
7120506572
120 TABLET, FILM COATED in 1 BOTTLE (71205-065-72)
ndc11
7120506590
90 TABLET, FILM COATED in 1 BOTTLE (71205-065-90)

Annotations

UNII (FDA Substance ID)

0VE05JYS2P

CYCLOBENZAPRINE HYDROCHLORIDE

RxCUI 52101

Orange Book

A208170

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": "71205-065_7cb81f85-9453-48a6-a1dd-ac81e2de0dba",
  "productndc": "71205-065",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208170",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "May 31, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "002",
        "approval_date": "May 31, 2017"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "May 31, 2017"
      }
    ],
    "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": "ANDA208170",
  "marketing_category": "ANDA",
  "nonproprietary_name": "cyclobenzaprine hydrochloride",
  "start_marketing_date": "20170531",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code M03BX08.

Access this data programmatically

Query CYCLOBENZAPRINE HYDROCHLORIDE 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.

Get a free API key Read the API docs