Cyclobenzaprine Hydrochloride

Product NDC: 66267-775
Requested package NDC: 66267-775-03
11-digit product format: 662670775
Labeler code: 66267
Product ID: 66267-775_b8a7d31b-81a0-174e-e053-2a95a90a9ed5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclobenzaprine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA090478
Marketing category: ANDA
Marketing start: 2012-04-02
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: 2022-12-31
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	66267-775	66267-775-03	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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2010-07-23
A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2010-07-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090478-001	AB
A090478-002	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 3 · 82 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	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A090478-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090478-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090478-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090478-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090478-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090478-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090478-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090478-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090478-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090478-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090478-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090478-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090478-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090478-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090478-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090478-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090478-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090478-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090478-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090478-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090478-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090478-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090478-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090478-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090478-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090478-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090478-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090478-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090478-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090478-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090478-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090478-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090478-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090478-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090478-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090478-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090478-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090478-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090478-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090478-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66267-775-04	EA - Each	66267-775	467e2041-5753-4b24-9050-bf2cc7af8ef6	1	2018-02-20

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	Cipla USA Inc.	575a31fb-04c5-4001-88a7-c33adbacc6a8	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	NuCare Pharmaceuticals, Inc.	4fbbc5b6-7aac-34e5-e054-00144ff88e88	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	NuCare Pharmaceuticals, Inc.	4a2b5f25-a333-15f3-e054-00144ff8d46c	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	Northwind Health Company, LLC	e04eea45-12ec-4d2b-e053-2a95a90a6b76	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	American Health Packaging	269bc278-963d-4830-816a-39bb4bf8c936	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	AvPAK	64f6d1be-4067-a5c7-2343-4aed651a0cac	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	AvPAK	e530fd1e-06fd-0432-e053-2995a90adf5f	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	Aphena Pharma Solutions - Tennessee, LLC	3bc7e2b4-e1a0-66e3-e063-6294a90a676a	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	EXELAN PHARMACEUTICALS, INC.	cf81da00-7c6d-4477-bb70-b3c2abea177a	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	NCS HealthCare of KY, LLC dba Vangard Labs	53688de9-2031-4d19-b422-4000285f7f47	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	Proficient Rx LP	ae6de8d8-33c2-40bd-9dd3-782c879a9d8f	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66267-775-03	66267077503	30 TABLET in 1 BOTTLE (66267-775-03)	30 tablet	2018-01-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP	NuCare Pharmaceuticals,Inc.	2021-01-11	HUMAN PRESCRIPTION DRUG LABEL	2