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NDC 65162-0541-50 Cyclobenzaprine Hydrochloride 10 mg/1 Details
Cyclobenzaprine Hydrochloride 10 mg/1
Cyclobenzaprine Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is CYCLOBENZAPRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Cyclobenzaprine is used with rest, physical therapy, and other measures to relax muscles and relieve pain and discomfort caused by strains, sprains, and other muscle injuries. Cyclobenzaprine is in a class of medications called skeletal muscle relaxants. It works by acting in the brain and nervous system to allow the muscles to relax.
Related Packages: 65162-0541-50Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Cyclobenzaprine
Product Information
NDC | 65162-0541 |
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Product ID | 65162-541_cb149fdb-eac2-4e98-9f7a-b06020dfac45 |
Associated GPIs | 75100050100305 |
GCN Sequence Number | 004681 |
GCN Sequence Number Description | cyclobenzaprine HCl TABLET 10 MG ORAL |
HIC3 | H6H |
HIC3 Description | SKELETAL MUSCLE RELAXANTS |
GCN | 18020 |
HICL Sequence Number | 001950 |
HICL Sequence Number Description | CYCLOBENZAPRINE HCL |
Brand/Generic | Generic |
Proprietary Name | Cyclobenzaprine Hydrochloride |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Cyclobenzaprine Hydrochloride |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET, FILM COATED |
Route | ORAL |
Active Ingredient Strength | 10 |
Active Ingredient Units | mg/1 |
Substance Name | CYCLOBENZAPRINE HYDROCHLORIDE |
Labeler Name | Amneal Pharmaceuticals LLC |
Pharmaceutical Class | Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA078218 |
Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0541-50 (65162054150)
NDC Package Code | 65162-541-50 |
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Billing NDC | 65162054150 |
Package | 500 TABLET, FILM COATED in 1 BOTTLE (65162-541-50) |
Marketing Start Date | 2010-02-18 |
NDC Exclude Flag | N |
Pricing Information | N/A |