cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler rising pharma holdings, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 10 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-783
Product ID 16571-783_0280b504-4a42-44f3-8a1a-34a20eac054a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078643
Listing Expiration 2026-12-31
Marketing Start 2008-09-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571783
Hyphenated Format 16571-783

Supplemental Identifiers

RxCUI
828320 828348
UPC
0316571782017 0316571783014
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 ANDA078643 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (16571-783-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (16571-783-10)
  • 500 TABLET, FILM COATED in 1 BOTTLE (16571-783-50)
source: ndc

Packages (3)

16571-783-01 100 TABLET, FILM COATED in 1 BOTTLE (16571-783-01) 16571-783-10 1000 TABLET, FILM COATED in 1 BOTTLE (16571-783-10) 16571-783-50 500 TABLET, FILM COATED in 1 BOTTLE (16571-783-50)

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": "0280b504-4a42-44f3-8a1a-34a20eac054a", "openfda": {"upc": ["0316571782017", "0316571783014"], "unii": ["0VE05JYS2P"], "rxcui": ["828320", "828348"], "spl_set_id": ["0280b504-4a42-44f3-8a1a-34a20eac054a"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (16571-783-01)", "package_ndc": "16571-783-01", "marketing_start_date": "20080926"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (16571-783-10)", "package_ndc": "16571-783-10", "marketing_start_date": "20080926"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (16571-783-50)", "package_ndc": "16571-783-50", "marketing_start_date": "20080926"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "16571-783_0280b504-4a42-44f3-8a1a-34a20eac054a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "16571-783", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078643", "marketing_category": "ANDA", "marketing_start_date": "20080926", "listing_expiration_date": "20261231"}