CYCLOBENZAPRINE HYDROCHLORIDE

Orange BookUNIISPLATC M03BX08

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeM03BX08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
5009047270
15 TABLET, FILM COATED in 1 BOTTLE (50090-4727-0)
ndc11
5009047271
20 TABLET, FILM COATED in 1 BOTTLE (50090-4727-1)
ndc11
5009047272
30 TABLET, FILM COATED in 1 BOTTLE (50090-4727-2)
ndc11
5009047273
60 TABLET, FILM COATED in 1 BOTTLE (50090-4727-3)
ndc11
5009047274
100 TABLET, FILM COATED in 1 BOTTLE (50090-4727-4)
ndc11
5009047276
7 TABLET, FILM COATED in 1 BOTTLE (50090-4727-6)
ndc11
5009047277
14 TABLET, FILM COATED in 1 BOTTLE (50090-4727-7)
ndc11
5009047278
21 TABLET, FILM COATED in 1 BOTTLE (50090-4727-8)
ndc11
5009047279
10 TABLET, FILM COATED in 1 BOTTLE (50090-4727-9)

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": "50090-4727_0d2d2af6-37df-43fe-8222-c1374734d48a",
  "productndc": "50090-4727",
  "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