cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: sa3, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler sa3, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 7.5 mg/1

Manufacturer
SA3, LLC

Identifiers & Regulatory

Product NDC 69420-1001
Product ID 69420-1001_e28f3c02-e3b3-44e6-895e-40f161d383c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078722
Listing Expiration 2026-12-31
Marketing Start 2015-03-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 694201001
Hyphenated Format 69420-1001

Supplemental Identifiers

RxCUI
828299
UPC
0369420100111 0369420100135
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 ANDA078722 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (69420-1001-1)
  • 100 TABLET, FILM COATED in 1 BOTTLE (69420-1001-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (69420-1001-3)
source: ndc

Packages (3)

69420-1001-1 1000 TABLET, FILM COATED in 1 BOTTLE (69420-1001-1) 69420-1001-2 100 TABLET, FILM COATED in 1 BOTTLE (69420-1001-2) 69420-1001-3 30 TABLET, FILM COATED in 1 BOTTLE (69420-1001-3)

Ingredients (1)

cyclobenzaprine hydrochloride (7.5 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": "e28f3c02-e3b3-44e6-895e-40f161d383c0", "openfda": {"upc": ["0369420100111", "0369420100135"], "unii": ["0VE05JYS2P"], "rxcui": ["828299"], "spl_set_id": ["a4ae481f-9e47-470a-b4d1-5a33c0df8761"], "manufacturer_name": ["SA3, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (69420-1001-1)", "package_ndc": "69420-1001-1", "marketing_start_date": "20150325"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (69420-1001-2)", "package_ndc": "69420-1001-2", "marketing_start_date": "20150325"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (69420-1001-3)", "package_ndc": "69420-1001-3", "marketing_start_date": "20150325"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "69420-1001_e28f3c02-e3b3-44e6-895e-40f161d383c0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "69420-1001", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "SA3, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "7.5 mg/1"}], "application_number": "ANDA078722", "marketing_category": "ANDA", "marketing_start_date": "20150325", "listing_expiration_date": "20261231"}