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
7133519620
40 TABLET, FILM COATED in 1 BOTTLE (71335-1962-0)
ndc11
7133519621
14 TABLET, FILM COATED in 1 BOTTLE (71335-1962-1)
ndc11
7133519622
84 TABLET, FILM COATED in 1 BOTTLE (71335-1962-2)
ndc11
7133519623
30 TABLET, FILM COATED in 1 BOTTLE (71335-1962-3)
ndc11
7133519624
20 TABLET, FILM COATED in 1 BOTTLE (71335-1962-4)
ndc11
7133519625
15 TABLET, FILM COATED in 1 BOTTLE (71335-1962-5)
ndc11
7133519626
60 TABLET, FILM COATED in 1 BOTTLE (71335-1962-6)
ndc11
7133519627
90 TABLET, FILM COATED in 1 BOTTLE (71335-1962-7)
ndc11
7133519628
56 TABLET, FILM COATED in 1 BOTTLE (71335-1962-8)
ndc11
7133519629
120 TABLET, FILM COATED in 1 BOTTLE (71335-1962-9)

Annotations

UNII (FDA Substance ID)

0VE05JYS2P

CYCLOBENZAPRINE HYDROCHLORIDE

RxCUI 52101

Orange Book

A213324

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": "71335-1962_081b5e7c-a504-8d76-e063-6294a90a821f",
  "productndc": "71335-1962",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "213324",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jul 6, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "002",
        "approval_date": "Jul 6, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Jul 5, 2020"
      }
    ],
    "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": "ANDA213324",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyclobenzaprine hydrochloride",
  "start_marketing_date": "20200706",
  "active_numerator_strength": "10"
}

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