Cyclobenzaprine Hydrochloride

Orange BookUNIISPLATC M03BX08

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeM03BX08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
6318709410
10 TABLET, FILM COATED in 1 BOTTLE (63187-094-10)
ndc11
6318709415
15 TABLET, FILM COATED in 1 BOTTLE (63187-094-15)
ndc11
6318709430
30 TABLET, FILM COATED in 1 BOTTLE (63187-094-30)
ndc11
6318709440
40 TABLET, FILM COATED in 1 BOTTLE (63187-094-40)
ndc11
6318709460
60 TABLET, FILM COATED in 1 BOTTLE (63187-094-60)
ndc11
6318709472
120 TABLET, FILM COATED in 1 BOTTLE (63187-094-72)
ndc11
6318709478
180 TABLET, FILM COATED in 1 BOTTLE (63187-094-78)
ndc11
6318709490
90 TABLET, FILM COATED in 1 BOTTLE (63187-094-90)

Annotations

UNII (FDA Substance ID)

0VE05JYS2P

CYCLOBENZAPRINE HYDROCHLORIDE

RxCUI 52101

Orange Book

A078048

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": "63187-094_6d258146-9e61-40a6-b433-d5fb21aecc5e",
  "productndc": "63187-094",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078048",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Feb 28, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Feb 28, 2011"
      }
    ],
    "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": "ANDA078048",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyclobenzaprine Hydrochloride",
  "start_marketing_date": "20140731",
  "active_numerator_strength": "5"
}

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