Cyclobenzaprine Hydrochloride

Product NDC
55700-857
11-digit product format
557000857
Labeler code
55700
Product ID
55700-857_0bbc0d26-4fb4-46bf-a591-2a5503c1fc5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA091281
Marketing category
ANDA
Marketing start
2020-04-17
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
15 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-857CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [QUALITY CARE PRODUCTS, LLC]3Legacy NDC20241220_f58894c3-301b-463a-853a-5ad39c082ab7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-857-605570008576060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55700-857-60) 2020-04-170000-00-00NoNoCurrent