Cyclobenzaprine Hydrochloride

Orange BookUNIISPLATC M03BX08

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeM03BX08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
7133526660
40 TABLET in 1 BOTTLE (71335-2666-0)
ndc11
7133526661
14 TABLET in 1 BOTTLE (71335-2666-1)
ndc11
7133526662
84 TABLET in 1 BOTTLE (71335-2666-2)
ndc11
7133526663
30 TABLET in 1 BOTTLE (71335-2666-3)
ndc11
7133526664
20 TABLET in 1 BOTTLE (71335-2666-4)
ndc11
7133526665
15 TABLET in 1 BOTTLE (71335-2666-5)
ndc11
7133526666
60 TABLET in 1 BOTTLE (71335-2666-6)
ndc11
7133526667
90 TABLET in 1 BOTTLE (71335-2666-7)
ndc11
7133526668
56 TABLET in 1 BOTTLE (71335-2666-8)
ndc11
7133526669
120 TABLET in 1 BOTTLE (71335-2666-9)

Annotations

UNII (FDA Substance ID)

0VE05JYS2P

CYCLOBENZAPRINE HYDROCHLORIDE

RxCUI 52101

Orange Book

A218936

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": "71335-2666_71c2dd8a-818a-444b-bdfb-9f8b6bc55f3a",
  "productndc": "71335-2666",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "218936",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Sep 12, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "002",
        "approval_date": "Sep 12, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Sep 12, 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": "ANDA218936",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyclobenzaprine Hydrochloride",
  "start_marketing_date": "20250219",
  "active_numerator_strength": "10"
}

Related drugs

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