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
7133521560
100 TABLET, FILM COATED in 1 BOTTLE (71335-2156-0)
ndc11
7133521561
30 TABLET, FILM COATED in 1 BOTTLE (71335-2156-1)
ndc11
7133521562
90 TABLET, FILM COATED in 1 BOTTLE (71335-2156-2)
ndc11
7133521563
21 TABLET, FILM COATED in 1 BOTTLE (71335-2156-3)
ndc11
7133521564
10 TABLET, FILM COATED in 1 BOTTLE (71335-2156-4)
ndc11
7133521565
15 TABLET, FILM COATED in 1 BOTTLE (71335-2156-5)
ndc11
7133521566
40 TABLET, FILM COATED in 1 BOTTLE (71335-2156-6)
ndc11
7133521567
60 TABLET, FILM COATED in 1 BOTTLE (71335-2156-7)
ndc11
7133521568
20 TABLET, FILM COATED in 1 BOTTLE (71335-2156-8)
ndc11
7133521569
120 TABLET, FILM COATED in 1 BOTTLE (71335-2156-9)

Annotations

UNII (FDA Substance ID)

0VE05JYS2P

CYCLOBENZAPRINE HYDROCHLORIDE

RxCUI 52101

Orange Book

A078643

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": "71335-2156_959dab21-96f5-44a0-a405-0343eeb428b5",
  "productndc": "71335-2156",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078643",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Sep 26, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Sep 26, 2008"
      }
    ],
    "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": "ANDA078643",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyclobenzaprine Hydrochloride",
  "start_marketing_date": "20080926",
  "active_numerator_strength": "5"
}

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