Cyclobenzaprine Hydrochloride

Orange BookUNIISPLATC M03BX08

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeM03BX08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
7278904603
3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-03)
ndc11
7278904604
4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-04)
ndc11
7278904606
6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-06)
ndc11
7278904610
10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-10)
ndc11
7278904612
12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-12)
ndc11
7278904614
14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-14)
ndc11
7278904620
20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-20)
ndc11
7278904630
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-30)
ndc11
7278904640
40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-40)
ndc11
7278904660
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-046-60)

Annotations

UNII (FDA Substance ID)

0VE05JYS2P

CYCLOBENZAPRINE HYDROCHLORIDE

RxCUI 52101

Orange Book

A077797

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": "72789-046_3403a5e2-c822-d823-e063-6394a90a7142",
  "productndc": "72789-046",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077797",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Feb 28, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Feb 28, 2007"
      }
    ],
    "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": "ANDA077797",
  "marketing_category": "ANDA",
  "nonproprietary_name": "cyclobenzaprine hydrochloride",
  "start_marketing_date": "20170330",
  "active_numerator_strength": "10"
}

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