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 · 9

ndc11
7642059902
2 TABLET, FILM COATED in 1 BOTTLE (76420-599-02)
ndc11
7642059905
5 TABLET, FILM COATED in 1 BOTTLE (76420-599-05)
ndc11
7642059907
7 TABLET, FILM COATED in 1 BOTTLE (76420-599-07)
ndc11
7642059910
100 TABLET, FILM COATED in 1 BOTTLE (76420-599-10)
ndc11
7642059914
14 TABLET, FILM COATED in 1 BOTTLE (76420-599-14)
ndc11
7642059920
20 TABLET, FILM COATED in 1 BOTTLE (76420-599-20)
ndc11
7642059930
30 TABLET, FILM COATED in 1 BOTTLE (76420-599-30)
ndc11
7642059960
60 TABLET, FILM COATED in 1 BOTTLE (76420-599-60)
ndc11
7642059990
90 TABLET, FILM COATED in 1 BOTTLE (76420-599-90)

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": "76420-599_04ab2bbb-1be5-1bfc-e063-6394a90a103e",
  "productndc": "76420-599",
  "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": "10"
}

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