CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC: 72888-014
11-digit product format: 728880014
Labeler code: 72888
Product ID: 72888-014_484568be-57f8-943e-e063-6394a90a589b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cyclobenzaprine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Advagen Pharma Limited
Application: ANDA208170
Marketing category: ANDA
Marketing start: 2017-05-31
Substance: CYCLOBENZAPRINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31
A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31
A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208170-001	AB
A208170-002	AB
A208170-003	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`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	A208170-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208170-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208170-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208170-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208170-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208170-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208170-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208170-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208170-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208170-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208170-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208170-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208170-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208170-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208170-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208170-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208170-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208170-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208170-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208170-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208170-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208170-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208170-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208170-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208170-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208170-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208170-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208170-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208170-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208170-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208170-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208170-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208170-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208170-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208170-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208170-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208170-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208170-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208170-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208170-001	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	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
b2169957-9083-412c-a175-3071860c2b43	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
72888-014-00	CYCLOBENZAPRINE HYDROCHLORIDE	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	6
72888-014-01	CYCLOBENZAPRINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100	6
72888-014-05	CYCLOBENZAPRINE HYDROCHLORIDE	500 in 1 BOTTLE	TABLET, FILM COATED	500	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72888-014-00	EA - Each	72888-014	cbdf5ff7-1121-463b-9580-8c63b9182f4b	1	2021-04-08
72888-014-01	EA - Each	72888-014	837677ef-a87c-46d4-8e7f-ca4fe7bedd68	1	2021-06-02
72888-014-05	EA - Each	72888-014	cf5acc31-b33b-4575-8e61-875fe40ad133	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72888-014	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [ADVAGEN PHARMA LIMITED]	5	Current NDC, Legacy NDC, 3 package rows	20241222_b2169957-9083-412c-a175-3071860c2b43.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 2 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	06da53af-5b46-4e32-a64c-9677e27ae229	2026-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Sportpharm LLC	d4e0f532-887b-40bb-80d6-5c4e5b1d64bf	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	4eaa675a-c24c-4043-8fdf-9d59e5e4f4d5	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Medcore LLC	1b834bd5-9ee6-42a4-819c-5c605fd18e1f	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Advagen Pharma Limited	b2169957-9083-412c-a175-3071860c2b43	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170 ndc (product): 72888-014
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NORTHSTAR RX LLC	2a3a13c3-116c-4e9e-a7f3-7ad7c80486c3	2026-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Northwind Health Company, LLC	c29cf8bd-2f63-ed4b-e053-2995a90ab6eb	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Northwind Health Company, LLC	dae3be94-a40c-5be1-e053-2a95a90a1484	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Northwind Health Company, LLC	f32bceda-1d24-322d-e053-2995a90aae1b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Northwind Health Company, LLC	f708cf0f-8373-14a2-e053-6394a90ab3fe	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	43ce2c79-ec4a-5120-e063-6394a90af6e1	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	eb908b77-741c-473a-b2e9-4f82167c3088	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	4923ac1f-d463-465b-9e99-7312aef87861	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	d6448bb1-9b8d-45f4-a14b-8328248e586e	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	PHOENIX RX LLC	3a90171b-aef3-0691-e063-6294a90a6560	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Coupler LLC	37c8c0d6-98c0-c1a5-e063-6394a90a7931	2025-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Redpharm Drug	0ab1b6f8-5d73-f97a-e063-6294a90a9fbf	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	30ca08c7-4ee3-2f37-e063-6294a90ae31a	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	418e3974-f7dd-4f27-bee5-3c2fb0531c4c	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	05641925-7b10-4b30-b6e8-44b416a5e77e	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170

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	8bef97d4-1b92-4316-8733-7751d627230f	14
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	8bef97d4-1b92-4316-8733-7751d627230f	14
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	fe81c68d-a579-4fe9-e053-6294a90a7bc0	8
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	fe81c68d-a579-4fe9-e053-6294a90a7bc0	8
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	b2169957-9083-412c-a175-3071860c2b43	6
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	b2169957-9083-412c-a175-3071860c2b43	6
828299	cyclobenzaprine HCl 7.5 MG Oral Tablet	PSN	b2169957-9083-412c-a175-3071860c2b43	6
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	b2169957-9083-412c-a175-3071860c2b43	6
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	b2169957-9083-412c-a175-3071860c2b43	6
828299	cyclobenzaprine hydrochloride 7.5 MG Oral Tablet	SCD	b2169957-9083-412c-a175-3071860c2b43	6
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	15aad4af-5c05-be36-e063-6294a90a9bb3	4
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	e343fd12-1ca2-418a-b690-f3e8f567596d	4
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	e343fd12-1ca2-418a-b690-f3e8f567596d	4
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	15aad4af-5c05-be36-e063-6294a90a9bb3	4
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	24653b10-bdf0-47c5-a1f4-dc25f3b86032	3
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	f32bceda-1d24-322d-e053-2995a90aae1b	3
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	0ab1b6f8-5d73-f97a-e063-6294a90a9fbf	3
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	00dbe051-a392-e2c6-e063-6394a90ab7f3	3
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	00dbe051-a392-e2c6-e063-6394a90ab7f3	3
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	f32bceda-1d24-322d-e053-2995a90aae1b	3
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	0ab1b6f8-5d73-f97a-e063-6294a90a9fbf	3
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	24653b10-bdf0-47c5-a1f4-dc25f3b86032	3
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	0f8ba2c0-38e7-a536-e063-6294a90ace8d	2
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	dfe7288c-a477-4f32-a9ab-00cc981a1a57	2
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	96207b29-033b-46a3-961f-e5125288d50f	2
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	dc3cc6b6-c692-4986-8ff7-3a6cd8c85cb2	2
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	418e3974-f7dd-4f27-bee5-3c2fb0531c4c	2
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	418e3974-f7dd-4f27-bee5-3c2fb0531c4c	2
828299	cyclobenzaprine HCl 7.5 MG Oral Tablet	PSN	418e3974-f7dd-4f27-bee5-3c2fb0531c4c	2
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	418e3974-f7dd-4f27-bee5-3c2fb0531c4c	2
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	dc3cc6b6-c692-4986-8ff7-3a6cd8c85cb2	2
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	dfe7288c-a477-4f32-a9ab-00cc981a1a57	2
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	96207b29-033b-46a3-961f-e5125288d50f	2
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	0f8ba2c0-38e7-a536-e063-6294a90ace8d	2
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	418e3974-f7dd-4f27-bee5-3c2fb0531c4c	2
828299	cyclobenzaprine hydrochloride 7.5 MG Oral Tablet	SCD	418e3974-f7dd-4f27-bee5-3c2fb0531c4c	2
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	3a90171b-aef3-0691-e063-6294a90a6560	1
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	37c8c0d6-98c0-c1a5-e063-6394a90a7931	1
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	30ca08c7-4ee3-2f37-e063-6294a90ae31a	1
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	3a90171b-aef3-0691-e063-6294a90a6560	1
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	37c8c0d6-98c0-c1a5-e063-6394a90a7931	1
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	30ca08c7-4ee3-2f37-e063-6294a90ae31a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72888-014-00	72888001400	1000 TABLET, FILM COATED in 1 BOTTLE (72888-014-00)	2017-05-31	0000-00-00	No	No	Current
72888-014-01	72888001401	100 TABLET, FILM COATED in 1 BOTTLE (72888-014-01)	2017-05-31	0000-00-00	No	No	Current
72888-014-05	72888001405	500 TABLET, FILM COATED in 1 BOTTLE (72888-014-05)	2017-05-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyclobenzaprine hydrochloride, USP	HAWAII REPACK, INC.	2026-09-15	HUMAN PRESCRIPTION DRUG LABEL	2
Cyclobenzaprine hydrochloride, USP	REMEDYREPACK INC.	2026-08-07	HUMAN PRESCRIPTION DRUG LABEL	15
Cyclobenzaprine hydrochloride, USP	Proficient Rx LP	2026-07-01	HUMAN PRESCRIPTION DRUG LABEL	3
Cyclobenzaprine hydrochloride, USP	ST. MARY'S MEDICAL PARK PHARMACY	2026-05-29	HUMAN PRESCRIPTION DRUG LABEL	8
Cyclobenzaprine hydrochloride, USP	Sportpharm LLC	2026-04-03	HUMAN PRESCRIPTION DRUG LABEL	3
Cyclobenzaprine hydrochloride, USP	ASCLEMED USA INC.	2026-04-03	HUMAN PRESCRIPTION DRUG LABEL	2
Cyclobenzaprine hydrochloride, USP	Preferred Pharmaceuticals Inc.	2026-04-01	HUMAN PRESCRIPTION DRUG LABEL	4
Cyclobenzaprine Hydrochloride	Direct_Rx	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL	4
Cyclobenzaprine hydrochloride, USP	Bryant Ranch Prepack	2026-03-04	HUMAN PRESCRIPTION DRUG LABEL	2
Cyclobenzaprine hydrochloride, USP	Advagen Pharma Limited \| Rubicon Research Limited	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	6
Cyclobenzaprine hydrochloride, USP	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Cyclobenzaprine hydrochloride, USP	PHOENIX RX LLC	2025-07-22	HUMAN PRESCRIPTION DRUG LABEL	1
Cyclobenzaprine hydrochloride, USP	Coupler LLC \| Rubicon Research Private Limited	2025-06-17	HUMAN PRESCRIPTION DRUG LABEL	1
Cyclobenzaprine hydrochloride, USP	Redpharm Drug	2025-04-09	HUMAN PRESCRIPTION DRUG LABEL	3
Cyclobenzaprine hydrochloride, USP	Advanced Rx of Tennessee, LLC	2025-03-20	HUMAN PRESCRIPTION DRUG LABEL	1
Cyclobenzaprine hydrochloride, USP	Bryant Ranch Prepack	2025-02-03	HUMAN PRESCRIPTION DRUG LABEL	2
Cyclobenzaprine hydrochloride, USP	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-02-03	HUMAN PRESCRIPTION DRUG LABEL	2