Cyclobenzaprine Hydrochloride

Product NDC: 59746-177
11-digit product format: 597460177
Labeler code: 59746
Product ID: 59746-177_a18ba005-b6de-4c5b-a837-489d74022084
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclobenzaprine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Jubilant Cadista Pharmaceuticals Inc.
Application: ANDA077563
Marketing category: ANDA
Marketing start: 2006-04-04
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077563-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-04-19
A077563-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-04-19
A077563-003	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077563-001	AB
A077563-002	AB
A077563-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A077563-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077563-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077563-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077563-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077563-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077563-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077563-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077563-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077563-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077563-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077563-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077563-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077563-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077563-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077563-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077563-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077563-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077563-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077563-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077563-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077563-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077563-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077563-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077563-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077563-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077563-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077563-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077563-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077563-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077563-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077563-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077563-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077563-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077563-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077563-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077563-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077563-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077563-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077563-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077563-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-04-19	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077563-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077563-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077563-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077563-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077563-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077563-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077563-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077563-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077563-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077563-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077563-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077563-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077563-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077563-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077563-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077563-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077563-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077563-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077563-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077563-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077563-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077563-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077563-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077563-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077563-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077563-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077563-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077563-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077563-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077563-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077563-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077563-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077563-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077563-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077563-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077563-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077563-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077563-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077563-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077563-001	AB	1	`1e350fbaab3a…`

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	10 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
828299	Internal RxNorm lookup
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
592871f6-0eb2-4624-9e10-bd8bf767c002	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
c2c26dc9-7e16-fc02-7eba-6b46ed3515ee	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59746-177-06	Cyclobenzaprine Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100		6
59746-177-10	Cyclobenzaprine Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59746-177-06	EA - Each	59746-177	62cf2fa8-752e-4cf4-b3ef-0c7de278c258	1	2012-07-24
59746-177-10	EA - Each	59746-177	ba04cb0b-4a0c-40e1-997d-75e4a9d556a4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
cyclobenzaprine hydrochloride	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
cyclobenzaprine	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Fd&c Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
lactose	INACTIVE INGREDIENT	J2B2A4N98G	CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
talc	INACTIVE INGREDIENT	7SEV7J4R1U	CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
cyclobenzaprine hydrochloride	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
cyclobenzaprine	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KAISER FOUNDATION HOSPITALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59746-177	CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]	6	Current NDC, Legacy NDC, 2 package rows	20250227_592871f6-0eb2-4624-9e10-bd8bf767c002.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	84be93c5-1526-465e-ab0b-c6d10ba1521d	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077563 application number: ANDA077563
Cyclobenzaprine HCL	CYCLOBENZAPRINE HCL	Direct_Rx	55683c5c-0f86-9a26-e063-6294a90a8e8c	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077563 application number: ANDA077563
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Coupler LLC	47d22c6d-49fb-f97c-e063-6294a90a6ba1	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077563 application number: ANDA077563
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Doc Rx	4c054230-1978-44d2-9467-ed1994619113	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077563 application number: ANDA077563
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	3bddfe25-00ba-747f-e063-6394a90a9ce6	2025-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077563 application number: ANDA077563
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	SOLA Pharmaceuticals, LLC	db930d05-3f92-41f1-888c-301b2c4565e6	2025-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077563 application number: ANDA077563
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	AvKARE	a264ab9f-cc12-325f-e053-2a95a90a53d9	2025-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077563 application number: ANDA077563
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	34f4e63a-1259-0226-e063-6294a90a9fc4	2025-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077563 application number: ANDA077563
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	3f1b9c8a-8f75-4b84-af0c-739815937fd7	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077563 application number: ANDA077563
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	dcef9b63-f998-4852-920d-c356623cea6a	2025-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077563 application number: ANDA077563
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Jubilant Cadista Pharmaceuticals Inc.	592871f6-0eb2-4624-9e10-bd8bf767c002	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077563 application number: ANDA077563 ndc (product): 59746-177
Cyclobenzaprine HCL	CYCLOBENZAPRINE HCL	Advanced Rx of Tennessee, LLC	afca2a49-6424-7b6a-e053-2a95a90ad41e	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077563 application number: ANDA077563

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	592871f6-0eb2-4624-9e10-bd8bf767c002	6
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	592871f6-0eb2-4624-9e10-bd8bf767c002	6
828299	cyclobenzaprine HCl 7.5 MG Oral Tablet	PSN	592871f6-0eb2-4624-9e10-bd8bf767c002	6
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	592871f6-0eb2-4624-9e10-bd8bf767c002	6
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	592871f6-0eb2-4624-9e10-bd8bf767c002	6
828299	cyclobenzaprine hydrochloride 7.5 MG Oral Tablet	SCD	592871f6-0eb2-4624-9e10-bd8bf767c002	6
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	b8ee8ddd-44ff-4149-9969-519fef14938a	4
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	b8ee8ddd-44ff-4149-9969-519fef14938a	4
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	a264ab9f-cc12-325f-e053-2a95a90a53d9	3
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	b336d6ef-8f76-6225-e053-2a95a90a8f33	3
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	b336d6ef-8f76-6225-e053-2a95a90a8f33	3
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	a264ab9f-cc12-325f-e053-2a95a90a53d9	3
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	db90bdea-e099-4a94-b6d2-f3fe98eb0392	2
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	0b9e0dc5-79f5-4ff6-99ca-33ecbda0bb52	2
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	db90bdea-e099-4a94-b6d2-f3fe98eb0392	2
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	0b9e0dc5-79f5-4ff6-99ca-33ecbda0bb52	2
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	e9063c42-e71a-4cce-9cd9-9ed6a192c6bb	1
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	9b4d726d-391e-4fbe-9958-baf8c638ec8f	1
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	879a4e55-012d-4988-b571-9a8cf94414dd	1
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	47d22c6d-49fb-f97c-e063-6294a90a6ba1	1
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	9b4d726d-391e-4fbe-9958-baf8c638ec8f	1
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	879a4e55-012d-4988-b571-9a8cf94414dd	1
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	e9063c42-e71a-4cce-9cd9-9ed6a192c6bb	1
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	47d22c6d-49fb-f97c-e063-6294a90a6ba1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59746-177-06	59746017706	100 TABLET, FILM COATED in 1 BOTTLE (59746-177-06)	2006-04-04	0000-00-00	No	No	Current
59746-177-10	59746017710	1000 TABLET, FILM COATED in 1 BOTTLE (59746-177-10)	2006-04-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyclobenzaprine Hydrochloride Tablets Rx Only	Preferred Pharmaceuticals Inc.	2026-07-15	HUMAN PRESCRIPTION DRUG LABEL	1
Cyclobenzaprine Hydrochloride Tablets Rx Only	Coupler LLC	2026-01-07	HUMAN PRESCRIPTION DRUG LABEL	1
Cyclobenzaprine Hydrochloride Tablets Rx Only	AvKARE	2025-07-24	HUMAN PRESCRIPTION DRUG LABEL	3
Cyclobenzaprine Hydrochloride Tablets Rx Only	Jubilant Cadista Pharmaceuticals Inc. \| Jubilant Generics Limited	2025-02-21	HUMAN PRESCRIPTION DRUG LABEL	6
Cyclobenzaprine 10mg tablets	RedPharm Drug, Inc. \| RedPharm Drug	2024-07-25	HUMAN PRESCRIPTION DRUG LABEL	3
Cyclobenzaprine Hydrochloride Tablets Rx Only	Aphena Pharma Solutions - Tennessee, LLC	2020-01-16	HUMAN PRESCRIPTION DRUG LABEL	1
Cyclobenzaprine Hydrochloride Tablets Rx Only	A-S Medication Solutions	2019-06-10	HUMAN PRESCRIPTION DRUG LABEL	2
Cyclobenzaprine Hydrochloride Tablets Rx Only	A-S Medication Solutions	2019-06-04	HUMAN PRESCRIPTION DRUG LABEL	2
Cyclobenzaprine Hydrochloride Tablets Rx Only	A-S Medication Solutions	2019-04-30	HUMAN PRESCRIPTION DRUG LABEL	4
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx Only	KAISER FOUNDATION HOSPITALS	2018-11-26	HUMAN PRESCRIPTION DRUG LABEL	2
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx Only	State of Florida DOH Central Pharmacy	2014-09-30	HUMAN PRESCRIPTION DRUG LABEL	1
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx Only	Contract Pharmacy Services-PA	2010-04-23	HUMAN PRESCRIPTION DRUG LABEL	1