cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: trupharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler trupharma llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 5 mg/1

Manufacturer
TruPharma LLC

Identifiers & Regulatory

Product NDC 52817-330
Product ID 52817-330_b8c3dbd2-89f7-215b-e053-2995a90a7f74
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208170
Listing Expiration 2026-12-31
Marketing Start 2017-05-31

Pharmacologic Class

Classes
centrally-mediated muscle relaxation [pe] muscle relaxant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52817330
Hyphenated Format 52817-330

Supplemental Identifiers

RxCUI
828299 828320 828348
UPC
0352817332103 0352817330109 0352817332004 0352817331106 0352817330505 0352817332509
UNII
0VE05JYS2P

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cyclobenzaprine hydrochloride (source: ndc)
Generic Name cyclobenzaprine hydrochloride (source: ndc)
Application Number ANDA208170 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (52817-330-10)
  • 500 TABLET, FILM COATED in 1 BOTTLE (52817-330-50)
source: ndc

Packages (2)

52817-330-10 100 TABLET, FILM COATED in 1 BOTTLE (52817-330-10) 52817-330-50 500 TABLET, FILM COATED in 1 BOTTLE (52817-330-50)

Ingredients (1)

cyclobenzaprine hydrochloride (5 mg/1)

Linked Drug Pages (1)

CYCLOBENZAPRINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b8c3dbd2-89f7-215b-e053-2995a90a7f74", "openfda": {"upc": ["0352817332103", "0352817330109", "0352817332004", "0352817331106", "0352817330505", "0352817332509"], "unii": ["0VE05JYS2P"], "rxcui": ["828299", "828320", "828348"], "spl_set_id": ["08adc97f-feef-46fb-ac75-f015b4f3a43a"], "manufacturer_name": ["TruPharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (52817-330-10)", "package_ndc": "52817-330-10", "marketing_start_date": "20170531"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (52817-330-50)", "package_ndc": "52817-330-50", "marketing_start_date": "20170531"}], "brand_name": "CYCLOBENZAPRINE HYDROCHLORIDE", "product_id": "52817-330_b8c3dbd2-89f7-215b-e053-2995a90a7f74", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "52817-330", "generic_name": "cyclobenzaprine hydrochloride", "labeler_name": "TruPharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CYCLOBENZAPRINE HYDROCHLORIDE", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA208170", "marketing_category": "ANDA", "marketing_start_date": "20170531", "listing_expiration_date": "20261231"}