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 · 10

ndc11
7642084100
1000 TABLET, FILM COATED in 1 BOTTLE (76420-841-00)
ndc11
7642084101
1 TABLET, FILM COATED in 1 BOTTLE (76420-841-01)
ndc11
7642084102
2 TABLET, FILM COATED in 1 BOTTLE (76420-841-02)
ndc11
7642084105
500 TABLET, FILM COATED in 1 BOTTLE (76420-841-05)
ndc11
7642084107
7 TABLET, FILM COATED in 1 BOTTLE (76420-841-07)
ndc11
7642084110
100 TABLET, FILM COATED in 1 BOTTLE (76420-841-10)
ndc11
7642084120
20 TABLET, FILM COATED in 1 BOTTLE (76420-841-20)
ndc11
7642084130
30 TABLET, FILM COATED in 1 BOTTLE (76420-841-30)
ndc11
7642084160
60 TABLET, FILM COATED in 1 BOTTLE (76420-841-60)
ndc11
7642084190
90 TABLET, FILM COATED in 1 BOTTLE (76420-841-90)

Annotations

UNII (FDA Substance ID)

0VE05JYS2P

CYCLOBENZAPRINE HYDROCHLORIDE

RxCUI 52101

Orange Book

A213324

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": "76420-841_3b4cbe13-2679-7313-e063-6294a90a97ae",
  "productndc": "76420-841",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "213324",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jul 6, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "002",
        "approval_date": "Jul 6, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Jul 5, 2020"
      }
    ],
    "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": "ANDA213324",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyclobenzaprine hydrochloride",
  "start_marketing_date": "20200706",
  "active_numerator_strength": "10"
}

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