Cyclobenzaprine Hydrochloride

Orange BookUNIISPLATC M03BX08

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeM03BX08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 11

ndc11
4306349401
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-01)
ndc11
4306349410
10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-10)
ndc11
4306349414
14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-14)
ndc11
4306349415
15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-15)
ndc11
4306349420
20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-20)
ndc11
4306349421
21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-21)
ndc11
4306349430
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-30)
ndc11
4306349460
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-60)
ndc11
4306349482
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-82)
ndc11
4306349490
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-90)
ndc11
4306349495
1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-95)

Annotations

UNII (FDA Substance ID)

0VE05JYS2P

CYCLOBENZAPRINE HYDROCHLORIDE

RxCUI 52101

Orange Book

A078048

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": "43063-494_4138b440-6586-92bc-e063-6394a90a3a3d",
  "productndc": "43063-494",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078048",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Feb 28, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Feb 28, 2011"
      }
    ],
    "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": "ANDA078048",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyclobenzaprine Hydrochloride",
  "start_marketing_date": "20140731",
  "active_numerator_strength": "5"
}

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