cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler macleods pharmaceuticals limited
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 15 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-272
Product ID 33342-272_fdf0f180-267f-434b-82f8-50c0a528d50c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207314
Listing Expiration 2026-12-31
Marketing Start 2024-07-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342272
Hyphenated Format 33342-272

Supplemental Identifiers

RxCUI
828353 828358
UPC
0333342273093 0333342272096
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 ANDA207314 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-272-09)
  • 10 BLISTER PACK in 1 CARTON (33342-272-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

33342-272-09 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-272-09) 33342-272-12 10 BLISTER PACK in 1 CARTON (33342-272-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

cyclobenzaprine hydrochloride (15 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": "fdf0f180-267f-434b-82f8-50c0a528d50c", "openfda": {"upc": ["0333342273093", "0333342272096"], "unii": ["0VE05JYS2P"], "rxcui": ["828353", "828358"], "spl_set_id": ["1af467cb-7b21-4084-bb54-4634e928b167"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-272-09)", "package_ndc": "33342-272-09", "marketing_start_date": "20240722"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-272-12)  / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "33342-272-12", "marketing_start_date": "20240722"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "33342-272_fdf0f180-267f-434b-82f8-50c0a528d50c", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "33342-272", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "15 mg/1"}], "application_number": "ANDA207314", "marketing_category": "ANDA", "marketing_start_date": "20240722", "listing_expiration_date": "20261231"}