cyclobenzaprine hydrochloride (71610-016)

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride

Generic Name cyclobenzaprine hydrochloride

Labeler aphena pharma solutions - tennessee, llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

cyclobenzaprine hydrochloride 10 mg/1

Manufacturer

Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-016

Product ID 71610-016_a35560e7-0593-4c49-87b1-8971ff6df820

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA078048

Listing Expiration 2026-12-31

Marketing Start 2014-07-31

Pharmacologic Class

Classes

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610016

Hyphenated Format 71610-016

Supplemental Identifiers

RxCUI

828348

UNII

0VE05JYS2P

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 ANDA078048 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1

source: ndc

Packaging

30 TABLET, FILM COATED in 1 BOTTLE (71610-016-30)
45 TABLET, FILM COATED in 1 BOTTLE (71610-016-45)
60 TABLET, FILM COATED in 1 BOTTLE (71610-016-53)
120 TABLET, FILM COATED in 1 BOTTLE (71610-016-70)
270 TABLET, FILM COATED in 1 BOTTLE (71610-016-92)

source: ndc

Packages (5)

71610-016-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-016-30) 71610-016-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-016-45) 71610-016-53 60 TABLET, FILM COATED in 1 BOTTLE (71610-016-53) 71610-016-70 120 TABLET, FILM COATED in 1 BOTTLE (71610-016-70) 71610-016-92 270 TABLET, FILM COATED in 1 BOTTLE (71610-016-92)

Ingredients (1)

cyclobenzaprine hydrochloride (10 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": "a35560e7-0593-4c49-87b1-8971ff6df820", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828348"], "spl_set_id": ["bb23383c-087a-4fb1-8917-edecd1ec4527"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-016-30)", "package_ndc": "71610-016-30", "marketing_start_date": "20200408"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71610-016-45)", "package_ndc": "71610-016-45", "marketing_start_date": "20171207"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71610-016-53)", "package_ndc": "71610-016-53", "marketing_start_date": "20200505"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (71610-016-70)", "package_ndc": "71610-016-70", "marketing_start_date": "20200505"}, {"sample": false, "description": "270 TABLET, FILM COATED in 1 BOTTLE (71610-016-92)", "package_ndc": "71610-016-92", "marketing_start_date": "20171227"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "71610-016_a35560e7-0593-4c49-87b1-8971ff6df820", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "71610-016", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078048", "marketing_category": "ANDA", "marketing_start_date": "20140731", "listing_expiration_date": "20261231"}