Cyclobenzaprine hydrochloride

Product NDC
55700-925
11-digit product format
557000925
Labeler code
55700
Product ID
55700-925_cd8640da-e890-44aa-a925-41aa29025462
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA213324
Marketing category
ANDA
Marketing start
2021-10-05
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-925-15EA - Each55700-925812bdb97-1716-46bc-8a58-e201189bbb9d12022-10-06
55700-925-20EA - Each55700-925735d2af2-af09-419d-b030-84fd2f21d0a312021-12-08
55700-925-30EA - Each55700-925e0701c7b-c799-4607-93f7-8bf39bbee4d012021-12-08
55700-925-60EA - Each55700-92537e0a160-b60e-4635-9f9d-561ccd631ed112021-12-08
55700-925-90EA - Each55700-925a08aec16-4bbc-4c9e-ae65-66cda1c3ad9812021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-925CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [QUALITY CARE PRODUCTS, LLC]9Legacy NDC20241220_19a54d55-a79a-48c0-89d0-dedd0dcf9f45.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-925-155570009251515 TABLET, FILM COATED in 1 BOTTLE (55700-925-15) 2022-09-060000-00-00NoNoCurrent
55700-925-205570009252020 TABLET, FILM COATED in 1 BOTTLE (55700-925-20) 2021-10-050000-00-00NoNoCurrent
55700-925-305570009253030 TABLET, FILM COATED in 1 BOTTLE (55700-925-30) 2021-10-050000-00-00NoNoCurrent
55700-925-605570009256060 TABLET, FILM COATED in 1 BOTTLE (55700-925-60) 2021-10-050000-00-00NoNoCurrent
55700-925-905570009259090 TABLET, FILM COATED in 1 BOTTLE (55700-925-90) 2021-10-050000-00-00NoNoCurrent