CYCLOBENZAPRINE HYDROCHLORIDE

Orange BookUNIISPLATC M03BX08

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeM03BX08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
7642001101
1 TABLET, FILM COATED in 1 BOTTLE (76420-011-01)
ndc11
7642001102
2 TABLET, FILM COATED in 1 BOTTLE (76420-011-02)
ndc11
7642001104
4 TABLET, FILM COATED in 1 BOTTLE (76420-011-04)
ndc11
7642001105
5 TABLET, FILM COATED in 1 BOTTLE (76420-011-05)
ndc11
7642001107
7 TABLET, FILM COATED in 1 BOTTLE (76420-011-07)
ndc11
7642001112
120 TABLET, FILM COATED in 1 BOTTLE (76420-011-12)
ndc11
7642001120
20 TABLET, FILM COATED in 1 BOTTLE (76420-011-20)
ndc11
7642001130
30 TABLET, FILM COATED in 1 BOTTLE (76420-011-30)
ndc11
7642001160
60 TABLET, FILM COATED in 1 BOTTLE (76420-011-60)
ndc11
7642001190
90 TABLET, FILM COATED in 1 BOTTLE (76420-011-90)

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": "76420-011_4ad5c599-4f5b-6372-e063-6394a90ae881",
  "productndc": "76420-011",
  "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