Cyclobenzaprine Hydrochloride

Orange BookUNIISPLATC M03BX08

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

Identification

ManufacturerNorthwind Health Company, LLC

CountryUS (United States)

ATC codeM03BX08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
5165597320
20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-20)
ndc11
5165597325
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-25)
ndc11
5165597352
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-52)
ndc11
5165597353
10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-53)
ndc11
5165597354
15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-54)
ndc11
5165597387
6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-87)

Annotations

UNII (FDA Substance ID)

0VE05JYS2P

CYCLOBENZAPRINE HYDROCHLORIDE

RxCUI 52101

Orange Book

A090478

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": "51655-973_4960a71d-10d7-6f03-e063-6394a90a710f",
  "productndc": "51655-973",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090478",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jul 23, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jul 23, 2010"
      }
    ],
    "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": "ANDA090478",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyclobenzaprine",
  "start_marketing_date": "20220504",
  "active_numerator_strength": "10"
}

Related drugs

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