Cyclobenzaprine Hydrochloride

Product NDC: 69420-1001
Requested package NDC: 69420-1001-3
11-digit product format: 694201001
Labeler code: 69420
Product ID: 69420-1001_96ca5b21-ea62-4cfe-ba93-d6a0034f3a3f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclobenzaprine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: SA3, LLC
Application: ANDA077563
Marketing category: ANDA
Marketing start: 2015-03-25
Substance: CYCLOBENZAPRINE HYDROCHLORIDE
Active strength: 7.5 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
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 · 129 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
2026-09-14 22:38:34	2026-08	A077563-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-04-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077563-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2006-04-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077563-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2017-08-25	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077563-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077563-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077563-003	AB	1	`84e616aacf4f…`
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…`

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	7.5 mg/1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
69420-1001-1	2022-02-18	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
69420-1001-1	2022-02-18	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
69420-1001-2	2022-02-18	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
69420-1001-2	2022-02-18	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
69420-1001-3	2022-02-18	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
69420-1001-3	2022-02-18	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
69420-1001-1	2022-01-28	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
69420-1001-1	2022-01-28	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
69420-1001-2	2022-01-28	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
69420-1001-2	2022-01-28	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
69420-1001-3	2022-01-28	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
69420-1001-3	2022-01-28	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69420-1001-1	Cyclobenzaprine Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	8
69420-1001-2	Cyclobenzaprine Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	8
69420-1001-3	Cyclobenzaprine Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69420-1001-1	EA - Each	69420-1001	e6ea69a7-5e27-4f6a-a746-14512576dd48	1	2015-05-05
69420-1001-2	EA - Each	69420-1001	2f4ecc40-7956-4cca-9600-72c4ab2186b4	1	2020-02-13
69420-1001-3	EA - Each	69420-1001	ba51461b-7957-4db7-8540-c071baa5269f	1	2020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]	2
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	2
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	2
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]	2
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69420-1001	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SA3, LLC]	7	Current NDC, Legacy NDC, 3 package rows	20220219_a4ae481f-9e47-470a-b4d1-5a33c0df8761.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 · 13 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	SA3, LLC	a4ae481f-9e47-470a-b4d1-5a33c0df8761	2025-06-23	Warnings, Adverse reactions	Exact identifier ndc (package): 69420-1001-3 ndc (product): 69420-1001 ndc11 (package): 69420100103
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
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
828299	cyclobenzaprine HCl 7.5 MG Oral Tablet	PSN	a4cc7965-2ba8-42e8-8c5c-b90145a6598a	12
828299	cyclobenzaprine HCl 7.5 MG Oral Tablet	PSN	794d350b-6c88-41d5-b68b-3e2c57ee2a4f	12
828299	cyclobenzaprine hydrochloride 7.5 MG Oral Tablet	SCD	a4cc7965-2ba8-42e8-8c5c-b90145a6598a	12
828299	cyclobenzaprine hydrochloride 7.5 MG Oral Tablet	SCD	794d350b-6c88-41d5-b68b-3e2c57ee2a4f	12
828299	cyclobenzaprine HCl 7.5 MG Oral Tablet	PSN	59f31ca3-1b28-4768-bb29-520f06f4a9f5	11
828299	cyclobenzaprine HCl 7.5 MG Oral Tablet	PSN	81917fa4-c79c-46e2-bfbb-507fc0d7ed1b	11
828299	cyclobenzaprine hydrochloride 7.5 MG Oral Tablet	SCD	59f31ca3-1b28-4768-bb29-520f06f4a9f5	11
828299	cyclobenzaprine hydrochloride 7.5 MG Oral Tablet	SCD	81917fa4-c79c-46e2-bfbb-507fc0d7ed1b	11
828299	cyclobenzaprine HCl 7.5 MG Oral Tablet	PSN	b062cb80-79a9-c5d8-e053-2a95a90aecfc	8
828299	cyclobenzaprine HCl 7.5 MG Oral Tablet	PSN	a4ae481f-9e47-470a-b4d1-5a33c0df8761	8
828299	cyclobenzaprine hydrochloride 7.5 MG Oral Tablet	SCD	b062cb80-79a9-c5d8-e053-2a95a90aecfc	8
828299	cyclobenzaprine hydrochloride 7.5 MG Oral Tablet	SCD	a4ae481f-9e47-470a-b4d1-5a33c0df8761	8
828299	cyclobenzaprine HCl 7.5 MG Oral Tablet	PSN	ae3a3f5c-fb64-4a43-be88-a2fc7c298ac1	6
828299	cyclobenzaprine hydrochloride 7.5 MG Oral Tablet	SCD	ae3a3f5c-fb64-4a43-be88-a2fc7c298ac1	6
828299	cyclobenzaprine HCl 7.5 MG Oral Tablet	PSN	903e3a5a-7c58-b70d-e053-2a95a90a6f9d	5
828299	cyclobenzaprine hydrochloride 7.5 MG Oral Tablet	SCD	903e3a5a-7c58-b70d-e053-2a95a90a6f9d	5
828299	cyclobenzaprine HCl 7.5 MG Oral Tablet	PSN	07e3ec53-f1f2-4231-aec6-1772a146ba88	4
828299	cyclobenzaprine hydrochloride 7.5 MG Oral Tablet	SCD	07e3ec53-f1f2-4231-aec6-1772a146ba88	4
828299	cyclobenzaprine HCl 7.5 MG Oral Tablet	PSN	492392c0-682f-2131-e054-00144ff8d46c	3
828299	cyclobenzaprine hydrochloride 7.5 MG Oral Tablet	SCD	492392c0-682f-2131-e054-00144ff8d46c	3
828299	cyclobenzaprine HCl 7.5 MG Oral Tablet	PSN	81e02f60-2f10-4368-ad1b-e628f0016975	2
828299	cyclobenzaprine HCl 7.5 MG Oral Tablet	PSN	48d950cf-dd93-4333-90eb-f519b9590de3	2
828299	cyclobenzaprine HCl 7.5 MG Oral Tablet	PSN	3a397e88-d267-feed-e063-6294a90a7710	2
828299	cyclobenzaprine HCl 7.5 MG Oral Tablet	PSN	ded16433-2462-4fec-8de7-2aed82f55f40	2
828299	cyclobenzaprine hydrochloride 7.5 MG Oral Tablet	SCD	81e02f60-2f10-4368-ad1b-e628f0016975	2
828299	cyclobenzaprine hydrochloride 7.5 MG Oral Tablet	SCD	48d950cf-dd93-4333-90eb-f519b9590de3	2
828299	cyclobenzaprine hydrochloride 7.5 MG Oral Tablet	SCD	3a397e88-d267-feed-e063-6294a90a7710	2
828299	cyclobenzaprine hydrochloride 7.5 MG Oral Tablet	SCD	ded16433-2462-4fec-8de7-2aed82f55f40	2
828299	cyclobenzaprine HCl 7.5 MG Oral Tablet	PSN	7d34c867-7857-480f-b91d-674b49b248b3	1
828299	cyclobenzaprine hydrochloride 7.5 MG Oral Tablet	SCD	7d34c867-7857-480f-b91d-674b49b248b3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69420-1001-3	69420100103	30 TABLET, FILM COATED in 1 BOTTLE (69420-1001-3)	2015-03-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	SA3, LLC	2026-09-28	HUMAN PRESCRIPTION DRUG LABEL	9
CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	2026-08-27	HUMAN PRESCRIPTION DRUG LABEL	6
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	Proficient Rx LP	2026-05-01	HUMAN PRESCRIPTION DRUG LABEL	6
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	Preferred Pharmaceuticals, Inc.	2026-04-01	HUMAN PRESCRIPTION DRUG LABEL	12
Cyclobenzaprine HCL Tablets	PHOENIX RX LLC	2026-01-16	HUMAN PRESCRIPTION DRUG LABEL	2
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	A-S Medication Solutions	2025-12-04	HUMAN PRESCRIPTION DRUG LABEL	11
Cyclobenzaprine HCL Tablets	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	8
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	Quality Care Products LLC	2024-12-17	HUMAN PRESCRIPTION DRUG LABEL	12
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	Bryant Ranch Prepack	2024-08-20	HUMAN PRESCRIPTION DRUG LABEL	11
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2024-05-07	HUMAN PRESCRIPTION DRUG LABEL	4
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	Unit Dose Services	2021-10-22	HUMAN PRESCRIPTION DRUG LABEL	2
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	NuCare Pharmaceuticals, Inc.	2021-02-23	HUMAN PRESCRIPTION DRUG LABEL	3
NOpioid-LMC Kit	Skya Health, LLC	2020-10-08	HUMAN PRESCRIPTION DRUG LABEL	1
NOpioid-LMC Kit	Skya Health, LLC	2020-10-01	HUMAN PRESCRIPTION DRUG LABEL	7
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	Aidarex Pharmaceuticals LLC	2015-12-10	HUMAN PRESCRIPTION DRUG LABEL	1
CYCLOBENZAPRINE HYDROCHLORIDE	DIRECT RX	2015-08-10	HUMAN PRESCRIPTION DRUG LABEL	2
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	All Pharma, LLC	2015-03-26	HUMAN PRESCRIPTION DRUG LABEL	2