cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

cyclobenzaprine hydrochloride 10 mg/1

Manufacturer
NORTHSTAR RX LLC

Identifiers & Regulatory

Product NDC 72603-312
Product ID 72603-312_4764d2fb-f80d-1435-e063-6294a90acd0b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208170
Listing Expiration 2027-12-31
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 72603312
Hyphenated Format 72603-312

Supplemental Identifiers

RxCUI
828299 828320 828348
UPC
0372603310023 0372603312027 0372603312034 0372603311013 0372603310016
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
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (72603-312-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (72603-312-02)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (72603-312-03)
source: ndc

Packages (3)

72603-312-01 100 TABLET, FILM COATED in 1 BOTTLE (72603-312-01) 72603-312-02 500 TABLET, FILM COATED in 1 BOTTLE (72603-312-02) 72603-312-03 1000 TABLET, FILM COATED in 1 BOTTLE (72603-312-03)

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": "4764d2fb-f80d-1435-e063-6294a90acd0b", "openfda": {"upc": ["0372603310023", "0372603312027", "0372603312034", "0372603311013", "0372603310016"], "unii": ["0VE05JYS2P"], "rxcui": ["828299", "828320", "828348"], "spl_set_id": ["2a3a13c3-116c-4e9e-a7f3-7ad7c80486c3"], "manufacturer_name": ["NORTHSTAR RX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (72603-312-01)", "package_ndc": "72603-312-01", "marketing_start_date": "20241101"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (72603-312-02)", "package_ndc": "72603-312-02", "marketing_start_date": "20241101"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (72603-312-03)", "package_ndc": "72603-312-03", "marketing_start_date": "20241101"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "72603-312_4764d2fb-f80d-1435-e063-6294a90acd0b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "72603-312", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "NORTHSTAR RX LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA208170", "marketing_category": "ANDA", "marketing_start_date": "20170531", "listing_expiration_date": "20271231"}