Cyclobenzaprine Hydrochloride

Product NDC: 71205-132
Requested package NDC: 71205-132-30
11-digit product format: 712050132
Labeler code: 71205
Product ID: 71205-132_5650efcf-e609-43b2-868f-03d375fcd7b2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclobenzaprine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA078722
Marketing category: ANDA
Marketing start: 2018-01-16
Marketing end: 0000-00-00
Substance: CYCLOBENZAPRINE HYDROCHLORIDE
Active strength: 8 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71205-132	71205-132-30	D	Discontinued by firm		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71205-132	71205-132-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71205-132	71205-132-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	2008-05-12
A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	2008-05-12
A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-05-12

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2008-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL		2008-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		2008-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2008-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL		2008-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		2008-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2008-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2008-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2008-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2008-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2008-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2008-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2008-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2008-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2008-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2008-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2008-05-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-05-12	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A078722-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078722-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078722-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078722-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078722-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078722-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078722-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078722-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078722-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078722-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078722-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078722-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078722-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078722-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078722-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078722-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078722-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078722-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078722-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078722-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078722-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078722-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078722-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078722-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078722-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078722-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078722-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078722-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078722-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078722-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078722-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078722-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078722-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078722-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078722-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078722-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078722-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078722-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078722-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078722-001	AB	1	`5d02ea3f76ae…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-132-20	EA - Each	71205-132	13eb6dcb-87fc-4d27-a570-de2273c1a940	1	2019-01-24
71205-132-60	EA - Each	71205-132	2fb11c4c-5887-4001-a28f-8179f309bd50	1	2018-11-06
71205-132-72	EA - Each	71205-132	e29d6c1c-317f-412e-831c-76d46da8d71d	1	2019-09-05
71205-132-90	EA - Each	71205-132	41fe5fb7-9829-475b-b260-7de057227639	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-132	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	5	Legacy NDC	20201031_10f568d1-caaa-4474-8728-242085da3cfd.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	ae3a3f5c-fb64-4a43-be88-a2fc7c298ac1	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078722 application number: ANDA078722
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	a4cc7965-2ba8-42e8-8c5c-b90145a6598a	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078722 application number: ANDA078722
Cyclobenzaprine HCL	CYCLOBENZAPRINE HCL	PHOENIX RX LLC	3a397e88-d267-feed-e063-6294a90a7710	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078722 application number: ANDA078722
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	81917fa4-c79c-46e2-bfbb-507fc0d7ed1b	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078722 application number: ANDA078722
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	SA3, LLC	a4ae481f-9e47-470a-b4d1-5a33c0df8761	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078722 application number: ANDA078722
Cyclobenzaprine HCL	CYCLOBENZAPRINE HCL	Advanced Rx of Tennessee, LLC	b062cb80-79a9-c5d8-e053-2a95a90aecfc	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078722 application number: ANDA078722
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Quality Care Products LLC	794d350b-6c88-41d5-b68b-3e2c57ee2a4f	2024-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078722 application number: ANDA078722
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	59f31ca3-1b28-4768-bb29-520f06f4a9f5	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078722 application number: ANDA078722
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	07e3ec53-f1f2-4231-aec6-1772a146ba88	2024-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078722 application number: ANDA078722

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-132-30	71205013230	30 TABLET, FILM COATED in 1 BOTTLE (71205-132-30)	2018-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	Proficient Rx LP	2020-10-01	HUMAN PRESCRIPTION DRUG LABEL	5