Cyclobenzaprine Hydrochloride

Product NDC: 43547-400
11-digit product format: 435470400
Labeler code: 43547
Product ID: 43547-400_0318717e-68e2-48bc-aa86-d34101d2bd25
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cyclobenzaprine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Solco Healthcare U.S., LLC
Application: ANDA077797
Marketing category: ANDA
Marketing start: 2017-03-30
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: 2026-12-31
Current FDA listing: Yes

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
A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2007-02-28
A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2007-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077797-001	AB
A077797-002	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	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077797-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2007-02-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077797-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2007-02-28	`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	A077797-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077797-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077797-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077797-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077797-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077797-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077797-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077797-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077797-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077797-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077797-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077797-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077797-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077797-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077797-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077797-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077797-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077797-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077797-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077797-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077797-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077797-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077797-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077797-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077797-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077797-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077797-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077797-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077797-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077797-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077797-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077797-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077797-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077797-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077797-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077797-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077797-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077797-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077797-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077797-002	AB	1	`782e0a99824c…`

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	10 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
828320	Internal RxNorm lookup
828348	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
f558863b-ea3f-4e4b-85e9-edb2573e7151	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, Effective, Related label table
NDC	Effective	Related label
43547-400-01	2020-03-05	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-09	2020-03-05	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-10	2020-03-05	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-11	2020-03-05	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-18	2020-03-05	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-27	2020-03-05	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-50	2020-03-05	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-51	2020-03-05	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-01	2020-01-31	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-09	2020-01-31	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-10	2020-01-31	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-11	2020-01-31	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-18	2020-01-31	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-27	2020-01-31	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-50	2020-01-31	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
43547-400-51	2020-01-31	CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43547-400-01	Cyclobenzaprine Hydrochloride	10 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	10	3
43547-400-09	Cyclobenzaprine Hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	3
43547-400-10	Cyclobenzaprine Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	3
43547-400-11	Cyclobenzaprine Hydrochloride	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1000	3
43547-400-18	Cyclobenzaprine Hydrochloride	180 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	180	3
43547-400-27	Cyclobenzaprine Hydrochloride	270 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	270	3
43547-400-50	Cyclobenzaprine Hydrochloride	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	3
43547-400-51	Cyclobenzaprine Hydrochloride	5000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	5000	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43547-400-10	EA - Each	43547-400	f4597b53-75d1-4759-b61c-b969e8bf9bf6	1	2017-05-03
43547-400-11	EA - Each	43547-400	1dd1fc73-8a41-46b0-be2e-88f3b3ef55a0	1	2017-05-03
43547-400-50	EA - Each	43547-400	49a9bfdc-6af0-43b4-b4ce-1a69b66e0ef8	1	2017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43547-400	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]	3	Current NDC, Legacy NDC, 8 package rows	20250402_f558863b-ea3f-4e4b-85e9-edb2573e7151.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	15c0c7aa-8c54-4040-a1bf-2a7b421ad33f	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	59b428fa-5013-4b2b-872f-16ba4a9d4f5d	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	9161cb5e-63e5-41d7-9bde-66c7b7b7a2f3	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	3aaa4808-7f2d-410c-9b6c-193549ec0845	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	7829a96a-3668-4d88-90e9-0ecbedb2bd7e	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	3baeda95-d098-437a-b360-87a9c3f3fd9b	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	aa29e260-fb77-415a-a505-3230d30c8945	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	afcad582-ab59-4f70-e053-2a95a90a04e4	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	4c51f56b-33c3-4611-bba8-876d9dde7aff	2024-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	90c7a982-6442-4241-a60b-b5dfab2abb71	2024-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	c86303a0-7c8b-415e-acac-1070b7d0d445	2024-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	68db3c3b-8da1-4852-90b0-3172f842aa02	2023-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Solco Healthcare U.S., LLC	f558863b-ea3f-4e4b-85e9-edb2573e7151	2022-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797 ndc (product): 43547-400
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	be5201bc-e1f1-41af-be46-4a8fbb223b86	2020-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	571fbb2b-24e0-4de3-8cfa-c267fc397b6c	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077797 application number: ANDA077797

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
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	4c51f56b-33c3-4611-bba8-876d9dde7aff	103
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	aa29e260-fb77-415a-a505-3230d30c8945	103
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	4c51f56b-33c3-4611-bba8-876d9dde7aff	103
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	aa29e260-fb77-415a-a505-3230d30c8945	103
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	aa429426-571d-4b5b-a599-6d71bed9f096	102
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	aa429426-571d-4b5b-a599-6d71bed9f096	102
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	c86303a0-7c8b-415e-acac-1070b7d0d445	101
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	c86303a0-7c8b-415e-acac-1070b7d0d445	101
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	90c7a982-6442-4241-a60b-b5dfab2abb71	100
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	90c7a982-6442-4241-a60b-b5dfab2abb71	100
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	7829a96a-3668-4d88-90e9-0ecbedb2bd7e	17
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	7829a96a-3668-4d88-90e9-0ecbedb2bd7e	17
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	3aaa4808-7f2d-410c-9b6c-193549ec0845	14
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	3aaa4808-7f2d-410c-9b6c-193549ec0845	14
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	52a30c84-3234-0aa5-e054-00144ff88e88	7
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	9161cb5e-63e5-41d7-9bde-66c7b7b7a2f3	7
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	afcad582-ab59-4f70-e053-2a95a90a04e4	7
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	52a30c84-3234-0aa5-e054-00144ff88e88	7
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	9161cb5e-63e5-41d7-9bde-66c7b7b7a2f3	7
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	afcad582-ab59-4f70-e053-2a95a90a04e4	7
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	643c0b19-01c9-e477-e053-2a91aa0a529c	6
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	643c0b19-01c9-e477-e053-2a91aa0a529c	6
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	43cc254b-6633-63dd-e054-00144ff88e88	3
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	f558863b-ea3f-4e4b-85e9-edb2573e7151	3
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	f558863b-ea3f-4e4b-85e9-edb2573e7151	3
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	43cc254b-6633-63dd-e054-00144ff88e88	3
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	43cc254b-6633-63dd-e054-00144ff88e88	3
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	f558863b-ea3f-4e4b-85e9-edb2573e7151	3
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	43cc254b-6633-63dd-e054-00144ff88e88	3
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	f558863b-ea3f-4e4b-85e9-edb2573e7151	3
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	571fbb2b-24e0-4de3-8cfa-c267fc397b6c	2
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	68db3c3b-8da1-4852-90b0-3172f842aa02	2
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	35fb2777-e4c5-41cb-8695-3ccabec4e0a4	2
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	68db3c3b-8da1-4852-90b0-3172f842aa02	2
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	571fbb2b-24e0-4de3-8cfa-c267fc397b6c	2
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	35fb2777-e4c5-41cb-8695-3ccabec4e0a4	2
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	bbb67b5b-d96b-9eca-e053-2a95a90ab5af	1
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	2f976e5f-b9c1-48e1-94f4-e85a8fd03fb9	1
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	be5201bc-e1f1-41af-be46-4a8fbb223b86	1
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	be5201bc-e1f1-41af-be46-4a8fbb223b86	1
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	bbb67b5b-d96b-9eca-e053-2a95a90ab5af	1
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	2f976e5f-b9c1-48e1-94f4-e85a8fd03fb9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43547-400-01	43547040001	10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-400-01)	2017-03-30	0000-00-00	No	No	Current
43547-400-09	43547040009	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-400-09)	2017-03-30	0000-00-00	No	No	Current
43547-400-10	43547040010	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-400-10)	2017-03-30	0000-00-00	No	No	Current
43547-400-11	43547040011	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-400-11)	2017-03-30	0000-00-00	No	No	Current
43547-400-18	43547040018	180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-400-18)	2017-03-30	0000-00-00	No	No	Current
43547-400-27	43547040027	270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-400-27)	2017-03-30	0000-00-00	No	No	Current
43547-400-50	43547040050	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-400-50)	2017-03-30	0000-00-00	No	No	Current
43547-400-51	43547040051	5000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-400-51)	2017-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2025-05-01	HUMAN PRESCRIPTION DRUG LABEL	7
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2025-04-30	HUMAN PRESCRIPTION DRUG LABEL	17
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2025-04-30	HUMAN PRESCRIPTION DRUG LABEL	14
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	Bryant Ranch Prepack	2025-02-10	HUMAN PRESCRIPTION DRUG LABEL	103
Cyclobenzaprine HCL tablets	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	7
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	Bryant Ranch Prepack	2024-11-27	HUMAN PRESCRIPTION DRUG LABEL	103
Cyclobenzaprine Hydrochloride - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-08-01	HUMAN PRESCRIPTION DRUG LABEL	7
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	Pharmasource Meds, LLC	2024-05-28	HUMAN PRESCRIPTION DRUG LABEL	2
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	Bryant Ranch Prepack	2024-01-31	HUMAN PRESCRIPTION DRUG LABEL	100
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	Bryant Ranch Prepack	2024-01-15	HUMAN PRESCRIPTION DRUG LABEL	101
CYCLOBENZAPRINE HYDROCHLORIDE	DIRECT RX	2023-04-17	HUMAN PRESCRIPTION DRUG LABEL	3
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-03-02	HUMAN PRESCRIPTION DRUG LABEL	2
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	Bryant Ranch Prepack	2023-02-27	HUMAN PRESCRIPTION DRUG LABEL	102
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	Lake Erie Medical DBA Quality Care Products LLC	2022-11-28	HUMAN PRESCRIPTION DRUG LABEL	7
CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL	2
CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL	2
CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL	2
CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL	2
CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL	2
CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL	2
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	Solco Healthcare U.S., LLC \| Prinston Pharmaceutical Inc. \| Prinston Laboratories	2022-08-22	HUMAN PRESCRIPTION DRUG LABEL	3
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	Bryant Ranch Prepack	2021-12-07	HUMAN PRESCRIPTION DRUG LABEL	100
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	Unit Dose Services	2021-10-22	HUMAN PRESCRIPTION DRUG LABEL	2
Cyclobenzaprine Hydrochloride - Central Packaging \| Central Packaging, LLC	Central Packaging \| Central Packaging, LLC	2021-02-19	HUMAN PRESCRIPTION DRUG LABEL	1
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only	NuCare Pharmaceuticals,Inc.	2021-02-12	HUMAN PRESCRIPTION DRUG LABEL	4