Cyclobenzaprine Hydrochloride

Orange BookUNIISPLATC M03BX08

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeM03BX08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 11

ndc11
6318781207
7 TABLET, FILM COATED in 1 BOTTLE (63187-812-07)
ndc11
6318781210
10 TABLET, FILM COATED in 1 BOTTLE (63187-812-10)
ndc11
6318781212
12 TABLET, FILM COATED in 1 BOTTLE (63187-812-12)
ndc11
6318781215
15 TABLET, FILM COATED in 1 BOTTLE (63187-812-15)
ndc11
6318781220
20 TABLET, FILM COATED in 1 BOTTLE (63187-812-20)
ndc11
6318781221
21 TABLET, FILM COATED in 1 BOTTLE (63187-812-21)
ndc11
6318781230
30 TABLET, FILM COATED in 1 BOTTLE (63187-812-30)
ndc11
6318781245
45 TABLET, FILM COATED in 1 BOTTLE (63187-812-45)
ndc11
6318781260
60 TABLET, FILM COATED in 1 BOTTLE (63187-812-60)
ndc11
6318781272
120 TABLET, FILM COATED in 1 BOTTLE (63187-812-72)
ndc11
6318781290
90 TABLET, FILM COATED in 1 BOTTLE (63187-812-90)

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": "63187-812_3afe19fb-b693-47f7-a08e-a46cc756ffda",
  "productndc": "63187-812",
  "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": "20160722",
  "active_numerator_strength": "10"
}

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