cyclobenzaprine hcl er

Generic: cyclobenzaprine hcl er

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hcl er
Generic Name cyclobenzaprine hcl er
Labeler direct_rx
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 15 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-362
Product ID 72189-362_2c4c9187-3348-d75f-e063-6394a90a9231
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021777
Listing Expiration 2026-12-31
Marketing Start 2022-07-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189362
Hyphenated Format 72189-362

Supplemental Identifiers

RxCUI
828358
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 hcl er (source: ndc)
Generic Name cyclobenzaprine hcl er (source: ndc)
Application Number NDA021777 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-362-60)
source: ndc

Packages (1)

72189-362-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-362-60)

Ingredients (1)

cyclobenzaprine hydrochloride (15 mg/1)

Linked Drug Pages (1)

Cyclobenzaprine HCL ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c4c9187-3348-d75f-e063-6394a90a9231", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828358"], "spl_set_id": ["e4a3383a-7b30-25b7-e053-2995a90a341b"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-362-60)", "package_ndc": "72189-362-60", "marketing_start_date": "20220725"}], "brand_name": "Cyclobenzaprine HCL ER", "product_id": "72189-362_2c4c9187-3348-d75f-e063-6394a90a9231", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "72189-362", "generic_name": "Cyclobenzaprine HCL ER", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine HCL ER", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "15 mg/1"}], "application_number": "NDA021777", "marketing_category": "NDA", "marketing_start_date": "20220725", "listing_expiration_date": "20261231"}