CYCLOBENZAPRINE HYDROCHLORIDE

Orange BookUNIISPLATC M03BX08

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

Identification

ManufacturerSportpharm LLC

CountryUS (United States)

ATC codeM03BX08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 14

ndc11
8576600300
1000 TABLET, FILM COATED in 1 BOTTLE (85766-003-00)
ndc11
8576600301
1 TABLET, FILM COATED in 1 BOTTLE (85766-003-01)
ndc11
8576600302
2 TABLET, FILM COATED in 1 BOTTLE (85766-003-02)
ndc11
8576600304
4 TABLET, FILM COATED in 1 BOTTLE (85766-003-04)
ndc11
8576600305
5 TABLET, FILM COATED in 1 BOTTLE (85766-003-05)
ndc11
8576600307
7 TABLET, FILM COATED in 1 BOTTLE (85766-003-07)
ndc11
8576600310
100 TABLET, FILM COATED in 1 BOTTLE (85766-003-10)
ndc11
8576600314
14 TABLET, FILM COATED in 1 BOTTLE (85766-003-14)
ndc11
8576600320
20 TABLET, FILM COATED in 1 BOTTLE (85766-003-20)
ndc11
8576600321
21 TABLET, FILM COATED in 1 BOTTLE (85766-003-21)
ndc11
8576600330
30 TABLET, FILM COATED in 1 BOTTLE (85766-003-30)
ndc11
8576600350
500 TABLET, FILM COATED in 1 BOTTLE (85766-003-50)
ndc11
8576600360
60 TABLET, FILM COATED in 1 BOTTLE (85766-003-60)
ndc11
8576600390
90 TABLET, FILM COATED in 1 BOTTLE (85766-003-90)

Annotations

UNII (FDA Substance ID)

0VE05JYS2P

CYCLOBENZAPRINE HYDROCHLORIDE

RxCUI 52101

Orange Book

A208170

ABABAB

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": "85766-003_4a8f971b-ad9c-5c85-e063-6394a90a9aff",
  "productndc": "85766-003",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208170",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "May 31, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "002",
        "approval_date": "May 31, 2017"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "May 31, 2017"
      }
    ],
    "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": "ANDA208170",
  "marketing_category": "ANDA",
  "nonproprietary_name": "cyclobenzaprine hydrochloride",
  "start_marketing_date": "20170531",
  "active_numerator_strength": "10"
}

Related drugs

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