cyclobenzaprine hcl er

Generic: cyclobenzaprine hcl er

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC 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 72189-389
Product ID 72189-389_2c4cd6df-c359-b1f7-e063-6394a90a9507
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021777
Listing Expiration 2026-12-31
Marketing Start 2022-11-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189389
Hyphenated Format 72189-389

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 (72189-389-60)
source: ndc

Packages (1)

72189-389-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-389-60)

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": "2c4cd6df-c359-b1f7-e063-6394a90a9507", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828358"], "spl_set_id": ["ed0b9acc-132f-64c0-e053-2995a90a198c"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-389-60)", "package_ndc": "72189-389-60", "marketing_start_date": "20221109"}], "brand_name": "Cyclobenzaprine HCL ER", "product_id": "72189-389_2c4cd6df-c359-b1f7-e063-6394a90a9507", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "72189-389", "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 AUTHORIZED GENERIC", "marketing_start_date": "20221109", "listing_expiration_date": "20261231"}