Cyclobenzaprine Hydrochloride

Orange BookUNIISPLATC M03BX08

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeM03BX08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
7642003301
1 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-033-01)
ndc11
7642003302
2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-033-02)
ndc11
7642003307
7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-033-07)
ndc11
7642003320
20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-033-20)
ndc11
7642003330
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-033-30)
ndc11
7642003360
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-033-60)
ndc11
7642003390
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-033-90)

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": "76420-033_f5f82b93-a80e-3ab8-e053-2995a90a68f5",
  "productndc": "76420-033",
  "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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