Cyclobenzaprine Hydrochloride

Product NDC: 0615-8665
11-digit product format: 006158665
Labeler code: 0615
Product ID: 0615-8665_e6356f61-5cae-4e1d-884f-7f75bbe5cb65
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclobenzaprine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: ANDA218936
Marketing category: ANDA
Marketing start: 2025-02-19
Substance: CYCLOBENZAPRINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A218936-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2024-09-12
A218936-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2024-09-12
A218936-003	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2024-09-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A218936-001	AB
A218936-002	AB
A218936-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A218936-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2024-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218936-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2024-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218936-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2024-09-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218936-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2024-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218936-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2024-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218936-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2024-09-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218936-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2024-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218936-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2024-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218936-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2024-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218936-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2024-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218936-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2024-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218936-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2024-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218936-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2024-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218936-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2024-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218936-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2024-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218936-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2024-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218936-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2024-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218936-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2024-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218936-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2024-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218936-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2024-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218936-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2024-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218936-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2024-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218936-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2024-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218936-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2024-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218936-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2024-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218936-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2024-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218936-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2024-09-12	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218936-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2024-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218936-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2024-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218936-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2024-09-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218936-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2024-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218936-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2024-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218936-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2024-09-12	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218936-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2024-09-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218936-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2024-09-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218936-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2024-09-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218936-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218936-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218936-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218936-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218936-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218936-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218936-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218936-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218936-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218936-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218936-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218936-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218936-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218936-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218936-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218936-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218936-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218936-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218936-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218936-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218936-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218936-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218936-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218936-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218936-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218936-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218936-003	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218936-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218936-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218936-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218936-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218936-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218936-003	AB	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218936-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218936-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218936-003	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Cyclobenzaprine Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CYCLOBENZAPRINE HYDROCHLORIDE	10 mg/1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	34e57aff-dc4b-4631-9d57-31020244835d	2026-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218936 application number: ANDA218936
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	6536b470-9a4e-4174-85b8-479f64cc3296	2025-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218936 application number: ANDA218936
Fexmid	CYCLOBENZAPRINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	41838966-de0b-4855-83b8-2ff6c764ed1f	2025-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218936 application number: ANDA218936
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	6018b6e9-938d-4fc9-86d7-1fd1d7bfcc58	2025-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218936 application number: ANDA218936

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0615-8665-05	00615866505	15 TABLET in 1 BLISTER PACK (0615-8665-05)	15 tablet	2026-09-08	No	No	Current
0615-8665-39	00615866539	30 TABLET in 1 BLISTER PACK (0615-8665-39)	30 tablet	2026-09-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyclobenzaprine Hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs \| Graviti Pharmaceuticals Private Limited	2026-09-14	HUMAN PRESCRIPTION DRUG LABEL	1