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
7642001001
100 TABLET, FILM COATED in 1 BOTTLE (76420-010-01)
ndc11
7642001005
500 TABLET, FILM COATED in 1 BOTTLE (76420-010-05)
ndc11
7642001012
120 TABLET, FILM COATED in 1 BOTTLE (76420-010-12)
ndc11
7642001015
15 TABLET, FILM COATED in 1 BOTTLE (76420-010-15)
ndc11
7642001030
30 TABLET, FILM COATED in 1 BOTTLE (76420-010-30)
ndc11
7642001060
60 TABLET, FILM COATED in 1 BOTTLE (76420-010-60)
ndc11
7642001090
90 TABLET, FILM COATED in 1 BOTTLE (76420-010-90)

Annotations

UNII (FDA Substance ID)

0VE05JYS2P

CYCLOBENZAPRINE HYDROCHLORIDE

RxCUI 52101

Orange Book

A078722

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": "76420-010_17d7186f-a791-93d2-e063-6294a90ac7d4",
  "productndc": "76420-010",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078722",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "May 12, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "7.5MG",
        "product_no": "002",
        "approval_date": "May 12, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "May 12, 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": "ANDA078722",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyclobenzaprine Hydrochloride",
  "start_marketing_date": "20170928",
  "active_numerator_strength": "7.5"
}

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