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
7642027101
1 TABLET, FILM COATED in 1 BOTTLE (76420-271-01)
ndc11
7642027102
2 TABLET, FILM COATED in 1 BOTTLE (76420-271-02)
ndc11
7642027107
7 TABLET, FILM COATED in 1 BOTTLE (76420-271-07)
ndc11
7642027110
100 TABLET, FILM COATED in 1 BOTTLE (76420-271-10)
ndc11
7642027112
120 TABLET, FILM COATED in 1 BOTTLE (76420-271-12)
ndc11
7642027115
15 TABLET, FILM COATED in 1 BOTTLE (76420-271-15)
ndc11
7642027120
20 TABLET, FILM COATED in 1 BOTTLE (76420-271-20)
ndc11
7642027130
30 TABLET, FILM COATED in 1 BOTTLE (76420-271-30)
ndc11
7642027160
60 TABLET, FILM COATED in 1 BOTTLE (76420-271-60)
ndc11
7642027190
90 TABLET, FILM COATED in 1 BOTTLE (76420-271-90)

Annotations

UNII (FDA Substance ID)

0VE05JYS2P

CYCLOBENZAPRINE HYDROCHLORIDE

RxCUI 52101

Orange Book

A071611

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": "76420-271_e7bfa09d-7e18-d2bf-e053-2995a90a9145",
  "productndc": "76420-271",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "071611",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "May 3, 1989"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Feb 3, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "003",
        "approval_date": "Feb 3, 2006"
      }
    ],
    "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": "ANDA071611",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyclobenzaprine Hydrochloride",
  "start_marketing_date": "20210720",
  "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