CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC: 51655-442
11-digit product format: 516550442
Labeler code: 51655
Product ID: 51655-442_b3a9b92a-0de7-446c-9815-81be40289927
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CYCLOBENZAPRINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Northwind Pharmaceuticals, LLC
Application: ANDA077797
Marketing category: ANDA
Marketing start: 2015-03-17
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: 2019-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-442-52	2026-01-08	C162847	48780-1	9d75b9d0-02d4-f424-e053-dadaa90a57ce	0038f081-a867-43ed-8415-9f0003871291
51655-442-52	2020-01-31	C162847	48780-1	9d75b9d0-02d4-f424-e053-dadaa90a57ce	0038f081-a867-43ed-8415-9f0003871291

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

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-442	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]	1	Legacy NDC	20150323_0038f081-a867-43ed-8415-9f0003871291.zip