cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 10 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-3422
Product ID 0093-3422_43707f11-5cf5-46a1-af67-c12153c11fd1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071611
Listing Expiration 2027-12-31
Marketing Start 2021-07-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00933422
Hyphenated Format 0093-3422

Supplemental Identifiers

RxCUI
828299 828320 828348
UPC
0300933421010 0300933422017 0300933420013
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 ANDA071611 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (0093-3422-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (0093-3422-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (0093-3422-10)
source: ndc

Packages (3)

0093-3422-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-3422-01) 0093-3422-05 500 TABLET, FILM COATED in 1 BOTTLE (0093-3422-05) 0093-3422-10 1000 TABLET, FILM COATED in 1 BOTTLE (0093-3422-10)

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": "43707f11-5cf5-46a1-af67-c12153c11fd1", "openfda": {"upc": ["0300933421010", "0300933422017", "0300933420013"], "unii": ["0VE05JYS2P"], "rxcui": ["828299", "828320", "828348"], "spl_set_id": ["1d9e34cc-eee9-4147-abf8-c810a80e39d2"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0093-3422-01)", "package_ndc": "0093-3422-01", "marketing_start_date": "20210720"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (0093-3422-05)", "package_ndc": "0093-3422-05", "marketing_start_date": "20210720"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (0093-3422-10)", "package_ndc": "0093-3422-10", "marketing_start_date": "20210720"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "0093-3422_43707f11-5cf5-46a1-af67-c12153c11fd1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "0093-3422", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA071611", "marketing_category": "ANDA", "marketing_start_date": "20210720", "listing_expiration_date": "20271231"}