Cyclobenzaprine Hydrochloride

Product NDC: 55700-981
11-digit product format: 557000981
Labeler code: 55700
Product ID: 55700-981_77971f19-d9e8-4452-ad42-5ed8a9224a4a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclobenzaprine Hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Quality Care Products, LLC
Application: NDA021777
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2022-08-09
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: 2023-12-31
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	55700-981		D	Discontinued by firm		2026-10-12
excluded package	package	55700-981	55700-981-60	D	Discontinued by firm		2026-10-12

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 · 4 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55700-981-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55700-981-60	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N021777-001	AMRIX	CYCLOBENZAPRINE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01
N021777-002	AMRIX	CYCLOBENZAPRINE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021777-001	AB
N021777-002	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 · 86 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	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	N021777-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021777-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021777-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021777-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021777-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021777-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021777-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021777-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021777-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021777-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021777-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021777-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021777-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021777-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021777-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021777-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021777-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021777-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021777-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021777-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021777-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021777-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021777-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021777-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021777-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021777-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021777-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021777-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021777-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021777-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021777-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021777-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021777-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021777-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021777-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021777-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021777-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021777-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021777-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021777-002	AB	1	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 382 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-001	7544372	2023-11-14	U-979			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-001	7790199	2023-11-14		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-001	7820203	2023-11-14		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-001	7829121	2023-11-14	U-1088			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-001	8877245	2023-11-14	U-979		2018-06-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-001	9375410	2023-11-14	U-1088		2016-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-001	9399025	2023-11-14	U-979	Drug product	2016-08-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-001	7387793	2025-02-26		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-002	7544372	2023-11-14	U-979			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-002	7790199	2023-11-14		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-002	7820203	2023-11-14		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-002	7829121	2023-11-14	U-1088			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-002	8877245	2023-11-14	U-979		2018-06-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-002	9375410	2023-11-14	U-1088		2016-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-002	9399025	2023-11-14	U-979	Drug product	2016-08-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-002	7387793	2025-02-26		Drug product		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021777-001	7544372	2023-11-14	U-979			`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-001	7790199	2023-11-14		Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-001	7820203	2023-11-14		Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-001	7829121	2023-11-14	U-1088			`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-001	8877245	2023-11-14	U-979		2018-06-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-001	9375410	2023-11-14	U-1088		2016-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-001	9399025	2023-11-14	U-979	Drug product	2016-08-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-001	7387793	2025-02-26		Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-002	7544372	2023-11-14	U-979			`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-002	7790199	2023-11-14		Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-002	7820203	2023-11-14		Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-002	7829121	2023-11-14	U-1088			`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-002	8877245	2023-11-14	U-979		2018-06-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-002	9375410	2023-11-14	U-1088		2016-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-002	9399025	2023-11-14	U-979	Drug product	2016-08-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-002	7387793	2025-02-26		Drug product		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021777-001	7544372	2023-11-14	U-979			`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021777-001	7790199	2023-11-14		Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021777-001	7820203	2023-11-14		Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021777-001	7829121	2023-11-14	U-1088			`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021777-001	8877245	2023-11-14	U-979		2018-06-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021777-001	9375410	2023-11-14	U-1088		2016-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021777-001	9399025	2023-11-14	U-979	Drug product	2016-08-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021777-001	7387793	2025-02-26		Drug product		`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-981-60	EA - Each	55700-981	3ccbd8ae-2ed3-40b3-bfe8-f60c91d3f153	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55700-981	CYCLOBENZAPRINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [QUALITY CARE PRODUCTS, LLC]	2	Legacy NDC	20241222_645517df-8a52-4fee-85a9-eca8c89e9069.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	30e61110-5bc8-4134-8456-538558479735	2026-09-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	3175d24d-e8a0-4f14-bed9-a60ad59ac7e7	2026-08-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	96b650d8-4ad5-42af-aa8c-aa0ac25abfb5	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	8a8c9479-b3ab-453a-bd8a-deaf38000742	2025-09-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Doc Rx	d4457b8c-fff8-4c19-8d5a-a667161e5446	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	PHOENIX RX LLC	3a116427-c427-c3bc-e063-6294a90ac539	2025-07-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	dd546a0e-e5be-4232-8ad8-fcd7d5f9a903	2025-05-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	2169667d-4f4b-472d-929b-8a0bcbddbe9c	2025-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777
Cyclobenzaprine HCL ER	CYCLOBENZAPRINE HCL ER	Direct_Rx	e4a3383a-7b30-25b7-e053-2995a90a341b	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777
Cyclobenzaprine HCL ER	CYCLOBENZAPRINE HCL ER	Direct_Rx	ed0b9acc-132f-64c0-e053-2995a90a198c	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777
Cyclobenzaprine HCL ER	CYCLOBENZAPRINE HCL	Advanced Rx Pharmacy of Tennessee, LLC	f8360da5-f1d3-1d89-e053-6294a90ad31c	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	259fb05a-4f45-9c8e-e063-6294a90a4484	2024-10-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	ca74d27a-f7c6-462d-a913-1cfa061bd8f3	2024-05-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777
AMRIX	CYCLOBENZAPRINE HYDROCHLORIDE	Cephalon, LLC	3902123b-1365-ac3c-0934-afff9eeeb1bd	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777

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
55700-981-60	55700098160	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55700-981-60)	2022-08-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyclobenzaprine Hydrochloride	Quality Care Products, LLC	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	2