Cyclobenzaprine Hydrochloride

Product NDC: 55700-857
11-digit product format: 557000857
Labeler code: 55700
Product ID: 55700-857_0bbc0d26-4fb4-46bf-a591-2a5503c1fc5a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclobenzaprine Hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA091281
Marketing category: ANDA
Marketing start: 2020-04-17
Marketing end: 0000-00-00
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: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55700-857		D	Discontinued by firm		2026-08-07
excluded package	package	55700-857	55700-857-60	D	Discontinued by firm		2026-08-07

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	55700-857		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-857	55700-857-60	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55700-857-60	2024-03-06	C162847	48780-1	f386c649-e7f8-0266-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
55700-857-60	2024-01-30	C162847	48780-1	f386c649-e7f8-0266-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
55700-857-60	2023-01-30	C162847	48780-1	f386c649-e7f8-0266-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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-857-60	EA - Each	55700-857	14918ba0-20e1-429b-89df-1406340280a5	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55700-857	CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [QUALITY CARE PRODUCTS, LLC]	3	Legacy NDC	20241220_f58894c3-301b-463a-853a-5ad39c082ab7.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-857-60	55700085760	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55700-857-60)	2020-04-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyclobenzaprine Hydrochloride	Quality Care Products, LLC	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL	3