Cyclobenzaprine Hydrochloride

Product NDC: 50090-5895
Requested package NDC: 50090-5895-2
11-digit product format: 500905895
Labeler code: 50090
Product ID: 50090-5895_f6521dca-bed2-4bd6-a78b-79d06a04692b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclobenzaprine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA071611
Marketing category: ANDA
Marketing start: 2021-07-20
Marketing end: 0000-00-00
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-5895	50090-5895-2	D	Discontinued by firm		2026-09-14

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 · 1 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	50090-5895	50090-5895-2	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
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 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	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071611-002	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2006-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071611-003	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2006-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071611-001	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1989-05-03	`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	A071611-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071611-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071611-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071611-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071611-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071611-003	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5895-0	EA - Each	50090-5895	e92be815-bd40-4ad3-afa8-4db2f1caf564	1	2022-06-06
50090-5895-1	EA - Each	50090-5895	8f90e615-9c97-412c-a75a-d46fa96a4d14	1	2022-06-06
50090-5895-2	EA - Each	50090-5895	f9c4a768-261e-4fae-97a7-3bf255cb3002	1	2022-06-06
50090-5895-3	EA - Each	50090-5895	8802cab4-9a97-4ad2-89b1-70742226a098	1	2022-06-06
50090-5895-4	EA - Each	50090-5895	8b419368-cfb8-4a99-8b8e-09e79022095a	1	2022-06-06
50090-5895-6	EA - Each	50090-5895	dc78e861-a1af-4609-afd8-4487016f8069	1	2022-06-06
50090-5895-7	EA - Each	50090-5895	6c07267c-da62-49cb-9c6b-641349351eca	1	2022-06-06
50090-5895-8	EA - Each	50090-5895	9a7bf3f0-5e57-4ceb-8e8c-476ffa20a96f	1	2022-06-06
50090-5895-9	EA - Each	50090-5895	ac2d680e-1bf1-4e30-832f-48df7e413675	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5895	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	4	Legacy NDC	20230915_efcae964-b670-455f-8fc6-f19d09d983b7.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	2026-05-01	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
50090-5895-2	50090589502	30 TABLET, FILM COATED in 1 BOTTLE (50090-5895-2)	2022-01-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyclobenzaprine Hydrochloride Tablets, USP Rx Only	A-S Medication Solutions	2023-09-14	HUMAN PRESCRIPTION DRUG LABEL	4