CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC: 61919-025
11-digit product format: 619190025
Labeler code: 61919
Product ID: 61919-025_3f63cd4b-805e-3d18-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CYCLOBENZAPRINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: DIRECT RX
Application: ANDA078722
Marketing category: ANDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: CYCLOBENZAPRINE HYDROCHLORIDE
Active strength: 8 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
51048710-225c-aa41-d0e7-eed095d02838	Product name	4	20250331
c2c26dc9-7e16-fc02-7eba-6b46ed3515ee	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-025-15	CYCLOBENZAPRINE HYDROCHLORIDE	15 in 1 BOTTLE	TABLET	15	2
61919-025-30	CYCLOBENZAPRINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30	2
61919-025-60	CYCLOBENZAPRINE HYDROCHLORIDE	60 in 1 BOTTLE	TABLET	60	2
61919-025-72	CYCLOBENZAPRINE HYDROCHLORIDE	120 in 1 BOTTLE	TABLET	120	2
61919-025-90	CYCLOBENZAPRINE HYDROCHLORIDE	90 in 1 BOTTLE	TABLET	90	2

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-025-15	EA - Each	61919-025	12d398cc-757b-4c08-85d2-fa09f0a22e4d	1	2015-02-02
61919-025-30	EA - Each	61919-025	555b8820-0451-4cdf-9766-cb0a2964d3f2	1	2015-02-02
61919-025-60	EA - Each	61919-025	06376cf7-4367-4045-8e77-a5715bc7a3c6	1	2015-02-02
61919-025-72	EA - Each	61919-025	65edf9ee-86be-4068-887e-9690833143e8	1	2015-02-02
61919-025-90	EA - Each	61919-025	6f817523-a935-45be-a59d-b5a88f5bea35	1	2015-02-02

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]	1
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-025	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [DIRECT RX]	2	Legacy NDC, 5 package rows	20161021_650a8b39-28fa-4515-a2fb-b2989e2331da.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE	6202-23-9	CYCLOBENZAPRINE HYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
828299	cyclobenzaprine HCl 7.5 MG Oral Tablet	PSN	650a8b39-28fa-4515-a2fb-b2989e2331da	2
828299	cyclobenzaprine hydrochloride 7.5 MG Oral Tablet	SCD	650a8b39-28fa-4515-a2fb-b2989e2331da	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
61919-025-15	61919002515	15 in 1 BOTTLE	Historical
61919-025-30	61919002530	30 in 1 BOTTLE	Historical
61919-025-60	61919002560	60 in 1 BOTTLE	Historical
61919-025-72	61919002572	120 in 1 BOTTLE	Historical
61919-025-90	61919002590	90 in 1 BOTTLE	Historical