CYCLOBENZAPRINE HYDROCHLORIDE

Orange BookUNIISPLATC M03BX08

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeM03BX08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
7133510990
100 TABLET, FILM COATED in 1 BOTTLE (71335-1099-0)
ndc11
7133510991
30 TABLET, FILM COATED in 1 BOTTLE (71335-1099-1)
ndc11
7133510992
90 TABLET, FILM COATED in 1 BOTTLE (71335-1099-2)
ndc11
7133510993
21 TABLET, FILM COATED in 1 BOTTLE (71335-1099-3)
ndc11
7133510994
10 TABLET, FILM COATED in 1 BOTTLE (71335-1099-4)
ndc11
7133510995
15 TABLET, FILM COATED in 1 BOTTLE (71335-1099-5)
ndc11
7133510996
40 TABLET, FILM COATED in 1 BOTTLE (71335-1099-6)
ndc11
7133510997
60 TABLET, FILM COATED in 1 BOTTLE (71335-1099-7)
ndc11
7133510998
20 TABLET, FILM COATED in 1 BOTTLE (71335-1099-8)
ndc11
7133510999
120 TABLET, FILM COATED in 1 BOTTLE (71335-1099-9)

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": "71335-1099_e1d36423-2d90-4161-933c-86e83e8c14a5",
  "productndc": "71335-1099",
  "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": "5"
}

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