Cyclobenzaprine Hydrochloride

Product NDC: 24979-035
11-digit product format: 249790035
Labeler code: 24979
Product ID: 24979-035_6d0e5e16-1e01-4ce6-9200-bdb5a651e923
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclobenzaprine Hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Upsher-Smith Laboratories, LLC
Application: ANDA091281
Marketing category: ANDA
Marketing start: 2019-03-01
Substance: CYCLOBENZAPRINE HYDROCHLORIDE
Active strength: 15 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
A091281-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-01-31
A091281-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091281-001	AB
A091281-002	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	A091281-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091281-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091281-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091281-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091281-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091281-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091281-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091281-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091281-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091281-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091281-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091281-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091281-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091281-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091281-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091281-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091281-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091281-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091281-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091281-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091281-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091281-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091281-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091281-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091281-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091281-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091281-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091281-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091281-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091281-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091281-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091281-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091281-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091281-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091281-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091281-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091281-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091281-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091281-001	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091281-002	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-01-31	`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	A091281-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091281-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091281-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091281-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091281-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091281-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091281-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091281-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091281-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091281-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091281-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091281-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091281-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091281-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091281-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091281-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091281-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091281-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091281-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091281-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091281-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091281-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091281-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091281-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091281-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091281-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091281-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091281-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091281-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091281-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091281-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091281-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091281-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091281-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091281-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091281-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091281-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091281-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091281-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091281-002	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	15 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
828353	Internal RxNorm lookup
828358	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
14f64ceb-ea5c-4d7c-a0c1-3f6a64847290	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
c2c26dc9-7e16-fc02-7eba-6b46ed3515ee	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
24979-035-04	2023-02-01	C162847	48780-1	f386c649-a4d9-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use CYCLOBENZAPRINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for CYCLOBENZAPRINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. CYCLOBENZAPRINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1977
24979-035-04	2023-01-30	C162847	48780-1	f386c649-a4d9-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use CYCLOBENZAPRINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for CYCLOBENZAPRINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. CYCLOBENZAPRINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1977

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
24979-035-04	Cyclobenzaprine Hydrochloride	60 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	60		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24979-035-04	EA - Each	24979-035	61d3a006-1ac7-4266-a843-494f1a70c57e	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24979-035	CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.]	7	Current NDC, Legacy NDC, 1 package rows	20241018_14f64ceb-ea5c-4d7c-a0c1-3f6a64847290.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	550d3e5a-c95f-4094-a500-1a02ea35a18d	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091281 application number: ANDA091281
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	fada6577-bcb8-422c-be37-08562919ebc9	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091281 application number: ANDA091281
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PHOENIX RX LLC	48c33e51-db07-af68-e063-6294a90a897e	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091281 application number: ANDA091281
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	ba659e1a-0091-45f6-b418-f4f36c9a2c79	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091281 application number: ANDA091281
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	14f64ceb-ea5c-4d7c-a0c1-3f6a64847290	2025-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091281 application number: ANDA091281 ndc (product): 24979-035
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	DIRECT RX	a512d34c-8164-0c04-e053-2995a90a1942	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091281 application number: ANDA091281
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	3dd2bde1-f06d-493a-91c7-22b28a5e1699	2025-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091281 application number: ANDA091281
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2998c9e6-2f60-ef35-e063-6394a90a7bc7	2024-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091281 application number: ANDA091281
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	bfdd9460-5dfa-4588-8f4f-9d227c1717d5	2024-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091281 application number: ANDA091281
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	d8112916-28ae-452c-8ec8-a4972e5f549b	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091281 application number: ANDA091281
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	ffd82a69-a64c-4399-8f5d-bddc70cdc3cf	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091281 application number: ANDA091281

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
828358	cyclobenzaprine HCl 15 MG 24HR Extended Release Oral Capsule	PSN	14f64ceb-ea5c-4d7c-a0c1-3f6a64847290	8
828353	cyclobenzaprine HCl 30 MG 24HR Extended Release Oral Capsule	PSN	14f64ceb-ea5c-4d7c-a0c1-3f6a64847290	8
828358	24 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral Capsule	SCD	14f64ceb-ea5c-4d7c-a0c1-3f6a64847290	8
828353	24 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral Capsule	SCD	14f64ceb-ea5c-4d7c-a0c1-3f6a64847290	8
828358	cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral Capsule	SY	14f64ceb-ea5c-4d7c-a0c1-3f6a64847290	8
828353	cyclobenzaprine hydrochloride 30 MG 24 HR Extended Release Oral Capsule	SY	14f64ceb-ea5c-4d7c-a0c1-3f6a64847290	8
828358	cyclobenzaprine HCl 15 MG 24HR Extended Release Oral Capsule	PSN	550d3e5a-c95f-4094-a500-1a02ea35a18d	5
828358	24 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral Capsule	SCD	550d3e5a-c95f-4094-a500-1a02ea35a18d	5
828358	cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral Capsule	SY	550d3e5a-c95f-4094-a500-1a02ea35a18d	5
828358	cyclobenzaprine HCl 15 MG 24HR Extended Release Oral Capsule	PSN	d8112916-28ae-452c-8ec8-a4972e5f549b	2
828358	cyclobenzaprine HCl 15 MG 24HR Extended Release Oral Capsule	PSN	ba659e1a-0091-45f6-b418-f4f36c9a2c79	2
828358	cyclobenzaprine HCl 15 MG 24HR Extended Release Oral Capsule	PSN	a512d34c-8164-0c04-e053-2995a90a1942	2
828358	24 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral Capsule	SCD	d8112916-28ae-452c-8ec8-a4972e5f549b	2
828358	24 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral Capsule	SCD	ba659e1a-0091-45f6-b418-f4f36c9a2c79	2
828358	24 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral Capsule	SCD	a512d34c-8164-0c04-e053-2995a90a1942	2
828358	cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral Capsule	SY	d8112916-28ae-452c-8ec8-a4972e5f549b	2
828358	cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral Capsule	SY	ba659e1a-0091-45f6-b418-f4f36c9a2c79	2
828358	cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral Capsule	SY	a512d34c-8164-0c04-e053-2995a90a1942	2
828358	cyclobenzaprine HCl 15 MG 24HR Extended Release Oral Capsule	PSN	3dd2bde1-f06d-493a-91c7-22b28a5e1699	1
828358	cyclobenzaprine HCl 15 MG 24HR Extended Release Oral Capsule	PSN	ffd82a69-a64c-4399-8f5d-bddc70cdc3cf	1
828358	cyclobenzaprine HCl 15 MG 24HR Extended Release Oral Capsule	PSN	bfdd9460-5dfa-4588-8f4f-9d227c1717d5	1
828358	cyclobenzaprine HCl 15 MG 24HR Extended Release Oral Capsule	PSN	2998c9e6-2f60-ef35-e063-6394a90a7bc7	1
828358	cyclobenzaprine HCl 15 MG 24HR Extended Release Oral Capsule	PSN	48c33e51-db07-af68-e063-6294a90a897e	1
828353	cyclobenzaprine HCl 30 MG 24HR Extended Release Oral Capsule	PSN	ffd82a69-a64c-4399-8f5d-bddc70cdc3cf	1
828353	cyclobenzaprine HCl 30 MG 24HR Extended Release Oral Capsule	PSN	3dd2bde1-f06d-493a-91c7-22b28a5e1699	1
828358	24 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral Capsule	SCD	2998c9e6-2f60-ef35-e063-6394a90a7bc7	1
828358	24 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral Capsule	SCD	ffd82a69-a64c-4399-8f5d-bddc70cdc3cf	1
828358	24 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral Capsule	SCD	3dd2bde1-f06d-493a-91c7-22b28a5e1699	1
828358	24 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral Capsule	SCD	bfdd9460-5dfa-4588-8f4f-9d227c1717d5	1
828358	24 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral Capsule	SCD	48c33e51-db07-af68-e063-6294a90a897e	1
828353	24 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral Capsule	SCD	3dd2bde1-f06d-493a-91c7-22b28a5e1699	1
828353	24 HR cyclobenzaprine hydrochloride 30 MG Extended Release Oral Capsule	SCD	ffd82a69-a64c-4399-8f5d-bddc70cdc3cf	1
828358	cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral Capsule	SY	bfdd9460-5dfa-4588-8f4f-9d227c1717d5	1
828358	cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral Capsule	SY	3dd2bde1-f06d-493a-91c7-22b28a5e1699	1
828358	cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral Capsule	SY	48c33e51-db07-af68-e063-6294a90a897e	1
828358	cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral Capsule	SY	2998c9e6-2f60-ef35-e063-6394a90a7bc7	1
828358	cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral Capsule	SY	ffd82a69-a64c-4399-8f5d-bddc70cdc3cf	1
828353	cyclobenzaprine hydrochloride 30 MG 24 HR Extended Release Oral Capsule	SY	3dd2bde1-f06d-493a-91c7-22b28a5e1699	1
828353	cyclobenzaprine hydrochloride 30 MG 24 HR Extended Release Oral Capsule	SY	ffd82a69-a64c-4399-8f5d-bddc70cdc3cf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
24979-035-04	24979003504	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-035-04)	2019-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyclobenzaprine Hydrochloride	Preferred Pharmaceuticals, Inc.	2026-04-01	HUMAN PRESCRIPTION DRUG LABEL	5
Cyclobenzaprine Hydrochloride	PHOENIX RX LLC	2026-01-19	HUMAN PRESCRIPTION DRUG LABEL	1
Cyclobenzaprine Hydrochloride	REMEDYREPACK INC.	2025-09-30	HUMAN PRESCRIPTION DRUG LABEL	2
Cyclobenzaprine Hydrochloride	Upsher-Smith Laboratories, LLC \| TWi Pharmaceuticals, Inc. \| Bora Pharmaceutical Laboratories Inc. Zhongli Plant \| Bora Pharmaceutical Laboratories Inc. Zhongli Plant Building II \| BORA PHARMACEUTICAL LABORATORIES INC.	2025-02-20	HUMAN PRESCRIPTION DRUG LABEL	8
CYCLOBENZAPRINE ER	DIRECT RX	2025-01-17	HUMAN PRESCRIPTION DRUG LABEL	2
Cyclobenzaprine Hydrochloride	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-01-07	HUMAN PRESCRIPTION DRUG LABEL	1
Cyclobenzaprine Hydrochloride	Quality Care Products, LLC	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL	3
Cyclobenzaprine Hydrochloride	Advanced Rx of Tennessee, LLC	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL	1
Cyclobenzaprine Hydrochloride	Bryant Ranch Prepack	2024-10-24	HUMAN PRESCRIPTION DRUG LABEL	1
Cyclobenzaprine Hydrochloride	Proficient Rx LP	2022-05-02	HUMAN PRESCRIPTION DRUG LABEL	2
Cyclobenzaprine Hydrochloride	Proficient Rx LP	2022-05-01	HUMAN PRESCRIPTION DRUG LABEL	1