Cyclobenzaprine Hydrochloride

Product NDC: 63629-1213
11-digit product format: 636291213
Labeler code: 63629
Product ID: 63629-1213_fc117ad1-470d-c16e-e053-6394a90a0461
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cyclobenzaprine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA077797
Marketing category: ANDA
Marketing start: 2017-03-30
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: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 63629-1213_fc117ad1-470d-c16e-e053-6394a90a0461
SPL ID: fc117ad1-470d-c16e-e053-6394a90a0461
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Cyclobenzaprine Hydrochloride
Generic name: cyclobenzaprine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Marketing start: 2017-03-30
Marketing category: ANDA
Application number: ANDA077797
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE]; Muscle Relaxant [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
CYCLOBENZAPRINE HYDROCHLORIDE	5 mg/1

Package NDC	Description	Marketing start	Sample
63629-1213-1	100 TABLET, FILM COATED in 1 BOTTLE (63629-1213-1)	2021-01-14	No

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

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
63629-1213-1	63629121301	100 TABLET, FILM COATED in 1 BOTTLE (63629-1213-1)	2021-01-14	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	Bryant Ranch Prepack	2023-05-19	HUMAN PRESCRIPTION DRUG LABEL	102