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
7642026901
1 TABLET, FILM COATED in 1 BOTTLE (76420-269-01)
ndc11
7642026902
2 TABLET, FILM COATED in 1 BOTTLE (76420-269-02)
ndc11
7642026907
7 TABLET, FILM COATED in 1 BOTTLE (76420-269-07)
ndc11
7642026910
100 TABLET, FILM COATED in 1 BOTTLE (76420-269-10)
ndc11
7642026915
15 TABLET, FILM COATED in 1 BOTTLE (76420-269-15)
ndc11
7642026920
20 TABLET, FILM COATED in 1 BOTTLE (76420-269-20)
ndc11
7642026930
30 TABLET, FILM COATED in 1 BOTTLE (76420-269-30)
ndc11
7642026960
60 TABLET, FILM COATED in 1 BOTTLE (76420-269-60)
ndc11
7642026990
90 TABLET, FILM COATED in 1 BOTTLE (76420-269-90)

Annotations

UNII (FDA Substance ID)

0VE05JYS2P

CYCLOBENZAPRINE HYDROCHLORIDE

RxCUI 52101

Orange Book

A071611

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": "76420-269_e7bfa09d-7e18-d2bf-e053-2995a90a9145",
  "productndc": "76420-269",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "071611",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "May 3, 1989"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Feb 3, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "003",
        "approval_date": "Feb 3, 2006"
      }
    ],
    "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": "ANDA071611",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyclobenzaprine Hydrochloride",
  "start_marketing_date": "20210720",
  "active_numerator_strength": "5"
}

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