Cyclobenzaprine hydrochloride

Product NDC: 51655-439
11-digit product format: 516550439
Labeler code: 51655
Product ID: 51655-439_96c19934-b215-4c4a-baa7-a3ac8a3285f5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclobenzaprine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Northwind Pharmaceuticals
Application: ANDA073144
Marketing category: ANDA
Marketing start: 2014-05-16
Marketing end: 0000-00-00
Substance: CYCLOBENZAPRINE HYDROCHLORIDE
Active strength: 10 mg/301
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-439-52	2026-01-13	C162847	48780-1	9d75b9d0-7c0c-f424-e053-dadaa90a57ce	0e2c0580-49d7-4bd5-85df-7a3591198ab0
51655-439-52	2020-01-31	C162847	48780-1	9d75b9d0-7c0c-f424-e053-dadaa90a57ce	0e2c0580-49d7-4bd5-85df-7a3591198ab0

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]	1
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-439	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]	1	Legacy NDC	20140516_0e2c0580-49d7-4bd5-85df-7a3591198ab0.zip