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 · 12

ndc11
7278903601
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-01)
ndc11
7278903615
15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-15)
ndc11
7278903621
21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-21)
ndc11
7278903630
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-30)
ndc11
7278903645
45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-45)
ndc11
7278903660
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-60)
ndc11
7278903682
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-82)
ndc11
7278903690
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-90)
ndc11
7278903693
180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-93)
ndc11
7278903694
270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-94)
ndc11
7278903695
1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-95)
ndc11
7278903698
120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-036-98)

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": "72789-036_34032d5b-b9ee-6ece-e063-6294a90a36ee",
  "productndc": "72789-036",
  "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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