CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC: 72189-283
11-digit product format: 721890283
Labeler code: 72189
Product ID: 72189-283_2c292ad7-a15f-7642-e063-6394a90a18b8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CYCLOBENZAPRINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DirectRx
Application: ANDA208170
Marketing category: ANDA
Marketing start: 2021-10-19
Substance: CYCLOBENZAPRINE HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-283-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-283-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-283-82	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-283-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-283-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-283-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-283-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-283-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-283-82	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-283-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-283-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-283-60	`0efc9e666f02…`	`f202fb6c5f17…`

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	RLD / RS	Approval date
A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31
A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31
A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208170-001	AB
A208170-002	AB
A208170-003	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`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	A208170-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208170-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208170-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208170-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208170-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208170-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208170-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208170-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208170-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208170-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208170-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208170-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208170-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208170-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208170-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208170-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208170-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208170-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208170-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208170-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208170-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208170-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208170-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208170-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208170-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208170-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208170-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208170-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208170-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208170-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208170-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208170-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208170-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208170-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208170-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208170-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208170-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208170-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208170-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208170-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: CYCLOBENZAPRINE HYDROCHLORIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CYCLOBENZAPRINE HYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0VE05JYS2P	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
828320	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ceb56ab8-4a76-6dee-e053-2995a90aab30	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72189-283-15	CYCLOBENZAPRINE HYDROCHLORIDE	15 in 1 BOTTLE	TABLET, FILM COATED	15	9
72189-283-20	CYCLOBENZAPRINE HYDROCHLORIDE	20 in 1 BOTTLE	TABLET, FILM COATED	20	9
72189-283-30	CYCLOBENZAPRINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30	9
72189-283-60	CYCLOBENZAPRINE HYDROCHLORIDE	60 in 1 BOTTLE	TABLET, FILM COATED	60	9
72189-283-82	CYCLOBENZAPRINE HYDROCHLORIDE	180 in 1 BOTTLE	TABLET, FILM COATED	180	9
72189-283-90	CYCLOBENZAPRINE HYDROCHLORIDE	90 in 1 BOTTLE	TABLET, FILM COATED	90	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-283-15	EA - Each	72189-283	0206a4a2-46d7-4a5e-ba5b-cbf4203e3a80	1	2023-03-13
72189-283-20	EA - Each	72189-283	ae6f9b2e-3461-4c5e-9fe7-826571d8451f	1	2022-03-09
72189-283-30	EA - Each	72189-283	d0fe0b76-d7e9-4dc5-b083-d1411cbdf481	1	2021-12-08
72189-283-60	EA - Each	72189-283	37bb5ce2-f935-4eac-aa19-04e941c23a1d	1	2022-06-06
72189-283-82	EA - Each	72189-283	89f75944-3003-4f2d-9cb3-abb8fd3122f7	1	2023-06-06
72189-283-90	EA - Each	72189-283	96717a09-bf43-411f-ac56-f6b9c885ba29	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-283	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECTRX]	9	Current NDC, Legacy NDC, 6 package rows	20250121_ceb56ab8-4a76-6dee-e053-2995a90aab30.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 2 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	06da53af-5b46-4e32-a64c-9677e27ae229	2026-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Sportpharm LLC	d4e0f532-887b-40bb-80d6-5c4e5b1d64bf	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	4eaa675a-c24c-4043-8fdf-9d59e5e4f4d5	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Medcore LLC	1b834bd5-9ee6-42a4-819c-5c605fd18e1f	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Advagen Pharma Limited	b2169957-9083-412c-a175-3071860c2b43	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NORTHSTAR RX LLC	2a3a13c3-116c-4e9e-a7f3-7ad7c80486c3	2026-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Northwind Health Company, LLC	c29cf8bd-2f63-ed4b-e053-2995a90ab6eb	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Northwind Health Company, LLC	dae3be94-a40c-5be1-e053-2a95a90a1484	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Northwind Health Company, LLC	f32bceda-1d24-322d-e053-2995a90aae1b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Northwind Health Company, LLC	f708cf0f-8373-14a2-e053-6394a90ab3fe	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	43ce2c79-ec4a-5120-e063-6394a90af6e1	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	eb908b77-741c-473a-b2e9-4f82167c3088	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	4923ac1f-d463-465b-9e99-7312aef87861	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	d6448bb1-9b8d-45f4-a14b-8328248e586e	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	PHOENIX RX LLC	3a90171b-aef3-0691-e063-6294a90a6560	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Coupler LLC	37c8c0d6-98c0-c1a5-e063-6394a90a7931	2025-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Redpharm Drug	0ab1b6f8-5d73-f97a-e063-6294a90a9fbf	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	30ca08c7-4ee3-2f37-e063-6294a90ae31a	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	418e3974-f7dd-4f27-bee5-3c2fb0531c4c	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	05641925-7b10-4b30-b6e8-44b416a5e77e	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	ceb56ab8-4a76-6dee-e053-2995a90aab30	9
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	ceb56ab8-4a76-6dee-e053-2995a90aab30	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-283-15	72189028315	15 TABLET, FILM COATED in 1 BOTTLE (72189-283-15)	2021-10-19		No	No	Current
72189-283-20	72189028320	20 TABLET, FILM COATED in 1 BOTTLE (72189-283-20)	2021-10-19	0000-00-00	No	No	Current
72189-283-30	72189028330	30 TABLET, FILM COATED in 1 BOTTLE (72189-283-30)	2021-10-19	0000-00-00	No	No	Current
72189-283-60	72189028360	60 TABLET, FILM COATED in 1 BOTTLE (72189-283-60)	2021-10-19	0000-00-00	No	No	Current
72189-283-82	72189028382	180 TABLET, FILM COATED in 1 BOTTLE (72189-283-82)	2021-10-19		No	No	Current
72189-283-90	72189028390	90 TABLET, FILM COATED in 1 BOTTLE (72189-283-90)	2021-10-19	0000-00-00	No	No	Current