Cyclobenzaprine Hydrochloride

Product NDC: 10702-006
11-digit product format: 107020006
Labeler code: 10702
Product ID: 10702-006_7d541fa9-d74b-5236-e053-2991aa0acc0e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclobenzaprine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: KVK-TECH, Inc.
Application: ANDA078048
Marketing category: ANDA
Marketing start: 2014-07-31
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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2011-02-28
A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2011-02-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078048-001	AB
A078048-002	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 · 84 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	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078048-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-02-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078048-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2011-02-28	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A078048-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078048-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078048-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078048-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078048-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078048-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078048-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078048-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078048-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078048-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078048-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078048-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078048-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078048-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078048-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078048-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078048-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078048-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078048-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078048-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078048-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078048-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078048-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078048-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078048-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078048-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078048-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078048-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078048-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078048-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078048-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078048-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078048-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078048-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078048-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078048-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078048-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078048-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078048-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078048-002	AB	1	`bb7c543d1eb4…`

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
5b756c04-e7b8-4efe-815a-3f3e020727fb	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	SPL version
10702-006-01	Cyclobenzaprine Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	8
10702-006-10	Cyclobenzaprine Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	8
10702-006-50	Cyclobenzaprine Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10702-006-01	EA - Each	10702-006	8e1c1136-06f2-462e-a322-4e5bba89526e	1	2013-05-02
10702-006-03	EA - Each	10702-006	4bede971-5080-405a-bee0-ac037a63cbfa	1	2013-05-02
10702-006-10	EA - Each	10702-006	733fc06a-c26d-4c9e-a34e-ab78a61c9b7e	1	2013-05-02
10702-006-50	EA - Each	10702-006	b7d0bea8-4a63-450c-b35b-3f96ba7054d1	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	6
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]	4
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]	4
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]	4
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]	4
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]	4
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	3
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	3
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	3
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	1
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10702-006	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]	8	Current NDC, Legacy NDC, 3 package rows	20181219_5b756c04-e7b8-4efe-815a-3f3e020727fb.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	e505c31b-4618-4e4f-8da6-92030464004f	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078048 application number: ANDA078048
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	American Health Packaging	5f321a03-ccfb-4c11-ac60-a461a5580c69	2024-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078048 application number: ANDA078048
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	f14bc532-e30f-490f-b97b-d0dab9a2ba0c	2021-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078048 application number: ANDA078048
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	bb23383c-087a-4fb1-8917-edecd1ec4527	2020-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078048 application number: ANDA078048
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	KVK-TECH, Inc.	5b756c04-e7b8-4efe-815a-3f3e020727fb	2018-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078048 application number: ANDA078048 ndc (product): 10702-006

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
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	e505c31b-4618-4e4f-8da6-92030464004f	25
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	e505c31b-4618-4e4f-8da6-92030464004f	25
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	5f321a03-ccfb-4c11-ac60-a461a5580c69	9
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	5f321a03-ccfb-4c11-ac60-a461a5580c69	9
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	5b756c04-e7b8-4efe-815a-3f3e020727fb	8
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	f14bc532-e30f-490f-b97b-d0dab9a2ba0c	8
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	5b756c04-e7b8-4efe-815a-3f3e020727fb	8
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	5b756c04-e7b8-4efe-815a-3f3e020727fb	8
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	5b756c04-e7b8-4efe-815a-3f3e020727fb	8
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	f14bc532-e30f-490f-b97b-d0dab9a2ba0c	8
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	5036946e-7b6e-27c4-e054-00144ff88e88	5
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	6d9dd102-855d-4be2-a9e6-5926f1dc3b4d	5
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	baefd44f-9e20-4f7e-b8aa-922a2558e042	5
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	6d9dd102-855d-4be2-a9e6-5926f1dc3b4d	5
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	baefd44f-9e20-4f7e-b8aa-922a2558e042	5
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	5036946e-7b6e-27c4-e054-00144ff88e88	5
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	119094a0-1c9a-49cf-e054-00144ff88e88	1
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	119094a0-1c9a-49cf-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
10702-006-01	10702000601	100 TABLET, FILM COATED in 1 BOTTLE (10702-006-01)	2014-07-31	0000-00-00	No	No	Current
10702-006-10	10702000610	1000 TABLET, FILM COATED in 1 BOTTLE (10702-006-10)	2014-07-31	0000-00-00	No	No	Current
10702-006-50	10702000650	500 TABLET, FILM COATED in 1 BOTTLE (10702-006-50)	2014-07-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP	PD-Rx Pharmaceuticals, Inc.	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	25
Cyclobenzaprine Hydrochloride Tablets, USP 8275321/0423 Rx only	American Health Packaging	2024-12-13	HUMAN PRESCRIPTION DRUG LABEL	9
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP	NCS HealthCare of KY, LLC dba Vangard Labs	2024-03-08	HUMAN PRESCRIPTION DRUG LABEL	4
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP	REMEDYREPACK INC.	2024-01-04	HUMAN PRESCRIPTION DRUG LABEL	12
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2023-01-05	HUMAN PRESCRIPTION DRUG LABEL	3
Cyclobenzaprine Hydrochloride - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-21	HUMAN PRESCRIPTION DRUG LABEL	5
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP	Proficient Rx LP	2021-10-01	HUMAN PRESCRIPTION DRUG LABEL	8
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP	Unit Dose Services	2021-03-09	HUMAN PRESCRIPTION DRUG LABEL	5
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP	Lake Erie Medical DBA Quality Care Products LLC	2020-01-27	HUMAN PRESCRIPTION DRUG LABEL	57
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP	Bryant Ranch Prepack	2020-01-19	HUMAN PRESCRIPTION DRUG LABEL	3
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP	1 Veterans Health \| PD-Rx Pharmaceuticals, Inc.	2019-11-07	HUMAN PRESCRIPTION DRUG LABEL	6
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP	KVK-TECH, Inc.	2018-12-19	HUMAN PRESCRIPTION DRUG LABEL	8
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP	A-S Medication Solutions	2018-02-21	HUMAN PRESCRIPTION DRUG LABEL	8
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP	NuCare Pharmaceuticals, Inc.	2018-01-08	HUMAN PRESCRIPTION DRUG LABEL	2
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP	Blenheim Pharmacal, Inc.	2015-03-18	HUMAN PRESCRIPTION DRUG LABEL	1