cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler upsher-smith laboratories, llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 15 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 24979-035
Product ID 24979-035_6d0e5e16-1e01-4ce6-9200-bdb5a651e923
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091281
Listing Expiration 2026-12-31
Marketing Start 2019-03-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24979035
Hyphenated Format 24979-035

Supplemental Identifiers

RxCUI
828353 828358
UPC
0324979036045 0324979035048
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 ANDA091281 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-035-04)
source: ndc

Packages (1)

24979-035-04 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-035-04)

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": "6d0e5e16-1e01-4ce6-9200-bdb5a651e923", "openfda": {"upc": ["0324979036045", "0324979035048"], "unii": ["0VE05JYS2P"], "rxcui": ["828353", "828358"], "spl_set_id": ["14f64ceb-ea5c-4d7c-a0c1-3f6a64847290"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-035-04)", "package_ndc": "24979-035-04", "marketing_start_date": "20190301"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "24979-035_6d0e5e16-1e01-4ce6-9200-bdb5a651e923", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "24979-035", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "15 mg/1"}], "application_number": "ANDA091281", "marketing_category": "ANDA", "marketing_start_date": "20190301", "listing_expiration_date": "20261231"}