Cyclobenzaprine Hydrochloride

Orange BookUNIISPLATC M03BX08

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

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeM03BX08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
3334227209
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-272-09)
ndc11
3334227212
10 BLISTER PACK in 1 CARTON (33342-272-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

0VE05JYS2P

CYCLOBENZAPRINE HYDROCHLORIDE

RxCUI 52101

Orange Book

A207314

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": "33342-272_fdf0f180-267f-434b-82f8-50c0a528d50c",
  "productndc": "33342-272",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "207314",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Jul 22, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Jul 22, 2024"
      }
    ],
    "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": "ANDA207314",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyclobenzaprine Hydrochloride",
  "start_marketing_date": "20240722",
  "active_numerator_strength": "15"
}

Related drugs

Other records sharing ATC code M03BX08.

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