Cyclobenzaprine HCL ER

Product NDC: 72189-362
11-digit product format: 721890362
Labeler code: 72189
Product ID: 72189-362_2c4c9187-3348-d75f-e063-6394a90a9231
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclobenzaprine HCL ER
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Direct_Rx
Application: NDA021777
Marketing category: NDA
Marketing start: 2022-07-25
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

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
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-362-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-362-60	`0efc9e666f02…`	`f202fb6c5f17…`

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
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 · 82 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
2026-02-19 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…`
2022-03-09 01:35 UTC	2022-03	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021777-001	AMRIX	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2007-02-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021777-002	AMRIX	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-02-01	`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	N021777-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021777-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021777-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021777-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021777-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021777-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021777-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021777-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021777-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021777-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021777-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021777-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021777-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021777-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021777-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021777-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021777-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021777-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021777-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021777-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021777-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021777-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021777-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021777-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021777-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021777-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021777-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021777-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021777-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021777-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021777-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021777-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021777-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021777-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021777-002	AB	1	`74a2ff9319b5…`
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…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cyclobenzaprine HCL ER
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
e4a3383a-7b30-25b7-e053-2995a90a341b	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-362-60	Cyclobenzaprine HCL ER	60 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-362-60	EA - Each	72189-362	50c3991d-3069-4975-9adb-34af8d9377c3	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-362	CYCLOBENZAPRINE HCL ER CAPSULE, EXTENDED RELEASE [DIRECT_RX]	2	Current NDC, Legacy NDC, 1 package rows	20250123_e4a3383a-7b30-25b7-e053-2995a90a341b.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	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	REMEDYREPACK INC.	30e61110-5bc8-4134-8456-538558479735	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021777 application number: NDA021777
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	3175d24d-e8a0-4f14-bed9-a60ad59ac7e7	2025-09-26	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 ndc (product): 72189-362
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

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	e4a3383a-7b30-25b7-e053-2995a90a341b	2
828358	24 HR cyclobenzaprine hydrochloride 15 MG Extended Release Oral Capsule	SCD	e4a3383a-7b30-25b7-e053-2995a90a341b	2
828358	cyclobenzaprine hydrochloride 15 MG 24 HR Extended Release Oral Capsule	SY	e4a3383a-7b30-25b7-e053-2995a90a341b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-362-60	72189036260	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-362-60)	2022-07-25	0000-00-00	No	No	Current