Cyclobenzaprine Hydrochloride

Product NDC
60760-889
11-digit product format
607600889
Labeler code
60760
Product ID
60760-889_ef53925b-2a8f-687b-e053-2a95a90af1a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
St Mary's Medical Park Pharmacy
Application
ANDA078643
Marketing category
ANDA
Marketing start
2022-05-17
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
60760-889-04EA - Each60760-889ac45a15b-38d2-4661-bc81-419db3ecc87712022-08-04
60760-889-15EA - Each60760-8899aebdd7b-3895-486d-9c6c-c6215c3472d412022-08-04
60760-889-20EA - Each60760-889731017fb-e355-49e5-9676-65028d0146d412023-01-09
60760-889-30EA - Each60760-889c6b48112-c798-490c-bf45-d6e77de99d2a12022-08-04
60760-889-40EA - Each60760-889c84683e0-a41d-404e-9441-05230a22ac5d12023-02-06
60760-889-90EA - Each60760-8897c02d39a-8983-40f1-a6f4-4e574963fb3c12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-889CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ST MARY'S MEDICAL PARK PHARMACY]4Legacy NDC20221209_e1aae221-4fa4-6a7e-e053-2a95a90af215.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-889-04607600889044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-889-04) 2022-05-170000-00-00NoNoCurrent
60760-889-156076008891515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-889-15) 2022-05-170000-00-00NoNoCurrent
60760-889-206076008892020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-889-20) 2022-09-170000-00-00NoNoCurrent
60760-889-306076008893030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-889-30) 2022-05-170000-00-00NoNoCurrent
60760-889-406076008894040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-889-40) 2022-11-300000-00-00NoNoCurrent
60760-889-906076008899090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-889-90) 2022-05-170000-00-00NoNoCurrent