NOpiod-TC

Product NDC: 73086-1001
11-digit product format: 730861001
Labeler code: 73086
Product ID: 73086-1001_a7be7b77-af6c-92e5-e053-2995a90ab492
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclobenzaprine Hydrochloride, Lidocaine, Menthol
Dosage form: KIT
Labeler: Skya Health, LLC
Application: ANDA078722
Marketing category: ANDA
Marketing start: 2020-05-15
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 132 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
2026-10-15 13:18:30	2026-09	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2008-05-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL		2008-05-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		2008-05-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2008-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL		2008-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		2008-05-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078722-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL		2008-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078722-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL		2008-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078722-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL		2008-05-12	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A078722-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078722-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078722-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078722-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078722-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078722-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078722-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078722-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078722-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078722-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078722-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078722-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078722-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078722-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078722-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078722-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078722-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078722-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078722-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078722-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078722-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078722-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078722-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078722-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078722-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078722-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078722-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078722-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078722-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078722-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078722-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078722-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078722-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078722-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078722-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078722-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078722-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078722-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078722-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A078722-002	AB	1	`1c564ffb4f44…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
73086-1001-1	EA - Each	73086-1001	5615f9ef-808a-4746-91a5-0e009f5b5875	1	2020-07-13

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	Direct_Rx	903e3a5a-7c58-b70d-e053-2a95a90a6f9d	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078722 application number: ANDA078722
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 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