CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC
70934-221
11-digit product format
709340221
Labeler code
70934
Product ID
70934-221_b8a741a8-2559-3904-e053-2995a90af3aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA208170
Marketing category
ANDA
Marketing start
2019-01-03
Marketing end
0000-00-00
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-221-302021-01-31C16284748780-1ba0f9c33-44ee-a910-e053-dadaa90a0b8587490c2f-6d17-7192-e053-2a95a90a0eb1
70934-221-302021-01-29C16284748780-1ba0f9c33-44ee-a910-e053-dadaa90a0b8587490c2f-6d17-7192-e053-2a95a90a0eb1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-221-30EA - Each70934-22147a381bc-7b35-4735-8e43-a766ee24f71612021-10-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-221-307093402213030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-221-30) 2019-01-030000-00-00NoNoCurrent