Cyclobenzaprine Hydrochloride

Product NDC
0378-0751
11-digit product format
003780751
Labeler code
0378
Product ID
0378-0751_30da9ca4-3bd1-4088-98ba-7e289ffc76be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA073144
Marketing category
ANDA
Marketing start
1991-05-30
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0751-01EA - Each0378-0751b3766038-d88d-467d-9923-a885cb81f00d12012-07-24
0378-0751-05EA - Each0378-0751f3c61b94-c9e3-4d22-8f2c-153c637c4e8e12012-07-24
0378-0751-10EA - Each0378-07515c1f13f0-e9cc-45fb-9995-0892c72035a912012-07-24
0378-0751-93EA - Each0378-0751c07031c7-4186-4b83-a76d-e6bd0667d45b12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-0751-0100378075101100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0751-01) 1991-05-300000-00-00NoNoCurrent
0378-0751-10003780751101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0751-10) 1991-05-300000-00-00NoNoCurrent