CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC: 72189-280
Requested package NDC: 72189-280-15
11-digit product format: 721890280
Labeler code: 72189
Product ID: 72189-280_4c5cd6ce-a63a-c9fd-e063-6394a90ab906
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CYCLOBENZAPRINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DirectRx
Application: ANDA213324
Marketing category: ANDA
Marketing start: 2021-10-07
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: 2027-12-31
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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06
A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06
A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213324-001	AB
A213324-002	AB
A213324-003	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 3 · 111 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	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213324-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2020-07-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213324-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2020-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213324-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2020-07-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 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	A213324-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213324-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213324-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213324-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213324-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213324-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213324-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213324-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213324-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213324-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213324-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213324-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213324-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213324-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213324-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213324-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213324-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213324-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213324-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213324-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213324-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213324-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213324-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213324-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213324-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213324-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213324-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213324-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213324-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213324-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213324-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213324-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213324-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213324-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213324-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213324-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213324-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213324-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213324-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213324-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: CYCLOBENZAPRINE HYDROCHLORIDE
Listing expiration: 2027-12-31

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
cdc5b438-6b6b-0cdd-e053-2a95a90a7f75	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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
72189-280-15	Cyclobenzaprine HCl
72189-280-30	Cyclobenzaprine HCl
72189-280-60	Cyclobenzaprine HCl
72189-280-82	Cyclobenzaprine HCl
72189-280-90	Cyclobenzaprine HCl

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72189-280-15	CYCLOBENZAPRINE HYDROCHLORIDE	15 in 1 BOTTLE	TABLET, FILM COATED	15	7
72189-280-20	CYCLOBENZAPRINE HYDROCHLORIDE	20 in 1 BOTTLE	TABLET, FILM COATED	20	7
72189-280-30	CYCLOBENZAPRINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30	7
72189-280-60	CYCLOBENZAPRINE HYDROCHLORIDE	60 in 1 BOTTLE	TABLET, FILM COATED	60	7
72189-280-82	CYCLOBENZAPRINE HYDROCHLORIDE	180 in 1 BOTTLE	TABLET, FILM COATED	180	7
72189-280-90	CYCLOBENZAPRINE HYDROCHLORIDE	90 in 1 BOTTLE	TABLET, FILM COATED	90	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-280-15	EA - Each	72189-280	d93953cc-8261-4012-9393-96d22f998329	1	2023-12-05
72189-280-30	EA - Each	72189-280	1601b9dd-caaf-4da0-816f-2530cc7ec437	1	2022-05-04
72189-280-60	EA - Each	72189-280	5e18c125-33a5-4265-a4bc-97a2c4c0a12b	1	2021-11-09
72189-280-82	EA - Each	72189-280	bbdaa237-806f-461a-9b61-3ff8236cefb9	1	2024-01-04
72189-280-90	EA - Each	72189-280	683b5ad3-d6b2-45f2-8cb7-ec0b0e54300a	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-280	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECTRX]	5	Current NDC, Legacy NDC, 6 package rows	20231212_cdc5b438-6b6b-0cdd-e053-2a95a90a7f75.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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	51d85ea8-8317-4a76-a108-20383f118ad4	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	16ed7d7e-862f-db36-e063-6394a90a02a5	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	106d9730-5938-8f27-e063-6294a90adc68	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	eb2b24b1-2851-440f-9075-b6a123a1fd5c	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	348c7ad4-b380-4b78-88f4-106b94079f52	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ac8ae965-af50-41d3-8df5-ca6daf4bbd1c	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	DirectRx	cdc5b438-6b6b-0cdd-e053-2a95a90a7f75	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324 ndc (package): 72189-280-15 ndc (product): 72189-280 ndc11 (package): 72189028015
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	6b06b11c-0546-4f6e-9509-ba612bbcb9fd	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	f3187074-6b55-44a3-b969-40a808eb034a	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	bf3c4c2e-b089-4f83-9c6a-7ca9d9abd3ba	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	1cb40f47-7fbb-4537-922d-04a08dd921c5	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PHOENIX RX LLC	4383b26f-c39f-3d6a-e063-6294a90aba03	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	37056cab-953e-43ba-9b4c-163a739a52f7	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	820dca15-5b7f-41e0-955f-73f942709264	2025-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fbd38abb-02ae-1a36-e053-6294a90abe65	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Redpharm Drug, Inc.	09d0e2fc-76a4-bb7d-e063-6394a90a4a7d	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine HCL	CYCLOBENZAPRINE HCL	Advanced Rx Pharmacy of Tennessee, LLC	c859f63a-09de-4eec-e053-2a95a90a312f	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	e332763b-00c6-41bf-84ae-a07d9ef79697	2024-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	f2286776-a7de-42dc-b745-d250e741eeb6	2024-05-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	c68d17e2-2311-8e17-e053-2995a90a565b	2024-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213324 application number: ANDA213324

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	cdc5b438-6b6b-0cdd-e053-2a95a90a7f75	7
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	cdc5b438-6b6b-0cdd-e053-2a95a90a7f75	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72189-280-15	72189028015	15 TABLET, FILM COATED in 1 BOTTLE (72189-280-15)	2021-10-07	No	No	Current