Cyclobenzaprine Hydrochloride

Orange BookUNIISPLATC M03BX08

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeM03BX08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7051834742
5 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3474-2)
ndc11
7051834744
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3474-4)
ndc11
7051834745
15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3474-5)
ndc11
7051834747
20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3474-7)
ndc11
7051834748
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3474-8)
ndc11
7051834749
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3474-9)

Annotations

UNII (FDA Substance ID)

0VE05JYS2P

CYCLOBENZAPRINE HYDROCHLORIDE

RxCUI 52101

Orange Book

A078643

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": "70518-3474_4f1afac0-e03f-256f-e063-6394a90ac5d4",
  "productndc": "70518-3474",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078643",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Sep 26, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Sep 26, 2008"
      }
    ],
    "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": "ANDA078643",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyclobenzaprine Hydrochloride",
  "start_marketing_date": "20220809",
  "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