Fexmid

Product NDC: 71205-059
11-digit product format: 712050059
Labeler code: 71205
Product ID: 71205-059_f716527d-6aaf-458a-9d2a-db3294b3c700
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclobenzaprine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA071611
Marketing category: ANDA
Marketing start: 2018-04-30
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: 2023-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71205-059		D	Discontinued by firm	2026-08-11
excluded package	package	71205-059	71205-059-14	D	Discontinued by firm	2026-08-11
excluded package	package	71205-059	71205-059-20	D	Discontinued by firm	2026-08-11
excluded package	package	71205-059	71205-059-30	D	Discontinued by firm	2026-08-11
excluded package	package	71205-059	71205-059-60	D	Discontinued by firm	2026-08-11
excluded package	package	71205-059	71205-059-72	D	Discontinued by firm	2026-08-11
excluded package	package	71205-059	71205-059-90	D	Discontinued by firm	2026-08-11

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71205-059-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71205-059-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71205-059-72	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71205-059-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71205-059-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71205-059-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71205-059-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71205-059-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71205-059-72	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71205-059-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71205-059-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71205-059-14	`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	TE codes	Approval date
A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03
A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03
A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071611-001	AB
A071611-002	AB
A071611-003	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 2 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
2024-05-31 18:47 UTC	2024-05	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`ea99ee380514…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A071611-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071611-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071611-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071611-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071611-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071611-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071611-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071611-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071611-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071611-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071611-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071611-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071611-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071611-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071611-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071611-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071611-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071611-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071611-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071611-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071611-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071611-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071611-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071611-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071611-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071611-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071611-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071611-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071611-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071611-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071611-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071611-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071611-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071611-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071611-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071611-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071611-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071611-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071611-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071611-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-059-14	EA - Each	71205-059	60c2cf73-7c39-471a-b3ac-cd3895b59fec	1	2022-03-09
71205-059-20	EA - Each	71205-059	eff3431f-b847-4184-b2bd-1056047bd00d	1	2019-04-11
71205-059-30	EA - Each	71205-059	efaa17ba-425a-4da2-84bc-c3e89c5eca9a	1	2018-11-06
71205-059-60	EA - Each	71205-059	437b3ce8-2f0e-4f91-9029-a3e003a613a9	1	2018-08-13
71205-059-72	EA - Each	71205-059	8c4d66f3-1623-4c3c-b341-6e819b845155	1	2018-08-13
71205-059-90	EA - Each	71205-059	821aa189-ea9e-4717-9892-82ebf69308f4	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-059	FEXMID (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]	7	Legacy NDC	20220626_2ca861a8-bbb2-4abb-95ba-054cfe825b5a.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	1d9e34cc-eee9-4147-abf8-c810a80e39d2	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071611 application number: ANDA071611
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1ac77323-7526-a129-e063-6394a90a641b	2024-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071611 application number: ANDA071611
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	f8dec4e2-3151-4a79-b194-a11a57ada0b6	2022-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071611 application number: ANDA071611

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
71205-059-14	71205005914	14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-059-14)	2022-01-05	0000-00-00	No	No	Current
71205-059-20	71205005920	20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-059-20)	2019-03-01	0000-00-00	No	No	Current
71205-059-30	71205005930	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-059-30)	2018-06-01	0000-00-00	No	No	Current
71205-059-60	71205005960	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-059-60)	2018-06-01	0000-00-00	No	No	Current
71205-059-72	71205005972	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-059-72)	2018-06-01	0000-00-00	No	No	Current
71205-059-90	71205005990	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-059-90)	2018-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fexmid ® 7.5 mg cyclobenzaprine HCl Tablets USP Rx only	Proficient Rx LP	2022-06-01	HUMAN PRESCRIPTION DRUG LABEL	7