CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC: 53746-540
11-digit product format: 537460540
Labeler code: 53746
Product ID: 53746-540_b0e32570-da9f-4fa8-a0a2-0334fce7ff7a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CYCLOBENZAPRINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA078218
Marketing category: ANDA
Marketing start: 2010-02-18
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18
A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19
A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078218-001	AB
A078218-002	AB
A078218-003	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.

Product history page 1 of 3 · 118 observed 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
2026-02-19 14:30 UTC	2026-02	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078218-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-06-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078218-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-11-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078218-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-04-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 118 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078218-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078218-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078218-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078218-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078218-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078218-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078218-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078218-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078218-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078218-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078218-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078218-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078218-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078218-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078218-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078218-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078218-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078218-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078218-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078218-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078218-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078218-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078218-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078218-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078218-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078218-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078218-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078218-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078218-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078218-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078218-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078218-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078218-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078218-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078218-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078218-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078218-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078218-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078218-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078218-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: CYCLOBENZAPRINE HYDROCHLORIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CYCLOBENZAPRINE HYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0VE05JYS2P	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
828320	Internal RxNorm lookup
828348	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
31bb92f6-ec8c-4636-8b07-8814417fe78e	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53746-540-01	CYCLOBENZAPRINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100	6
53746-540-05	CYCLOBENZAPRINE HYDROCHLORIDE	500 in 1 BOTTLE	TABLET, FILM COATED	500	6
53746-540-10	CYCLOBENZAPRINE HYDROCHLORIDE	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53746-540	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	6	Current NDC, Legacy NDC, 3 package rows	20240101_31bb92f6-ec8c-4636-8b07-8814417fe78e.zip

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	Amneal Pharmaceuticals LLC	390151d4-5fcb-46e2-92e6-de184827f43d	2024-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078218 application number: ANDA078218
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	31bb92f6-ec8c-4636-8b07-8814417fe78e	2023-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078218 application number: ANDA078218 ndc (product): 53746-540
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	3cdde96c-9fc9-4698-872a-25c05318ecb5	2021-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078218 application number: ANDA078218
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	50aa421f-1d73-4b43-8528-2617ef2507dc	2019-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078218 application number: ANDA078218

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	31bb92f6-ec8c-4636-8b07-8814417fe78e	6
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	31bb92f6-ec8c-4636-8b07-8814417fe78e	6
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	31bb92f6-ec8c-4636-8b07-8814417fe78e	6
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	31bb92f6-ec8c-4636-8b07-8814417fe78e	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53746-540-01	53746054001	100 TABLET, FILM COATED in 1 BOTTLE (53746-540-01)	2010-02-18	0000-00-00	No	No	Current
53746-540-05	53746054005	500 TABLET, FILM COATED in 1 BOTTLE (53746-540-05)	2010-02-18	0000-00-00	No	No	Current
53746-540-10	53746054010	1000 TABLET, FILM COATED in 1 BOTTLE (53746-540-10)	2010-02-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyclobenzaprine Hydrochloride Tablets, USP Rx only	Amneal Pharmaceuticals of New York LLC	2023-12-31	HUMAN PRESCRIPTION DRUG LABEL	6