Cyclobenzaprine Hydrochloride

Product NDC: 65862-191
11-digit product format: 658620191
Labeler code: 65862
Product ID: 65862-191_13f9bb96-7677-4506-befe-d7afa9b13cab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclobenzaprine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA078643
Marketing category: ANDA
Marketing start: 2008-09-26
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

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
unfinished product	product	65862-191		UNFINISHED	Active or certified unfinished drug listing		2026-08-10
unfinished package	package	65862-191	65862-191-81	UNFINISHED	Active or certified unfinished drug listing		2026-08-10

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 · 42 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 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-191-81	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-191-81	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-191-81	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-191-81	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-191-81	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-191-81	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-191-81	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-191-81	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-191-81	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-191-81	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-191-81	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-191-81	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-191-81	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-191-81	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-191-81	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	65862-191-81	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	65862-191-81	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	65862-191-81	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	65862-191-81	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	65862-191-81	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	65862-191-81	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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
A078643-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2008-09-26
A078643-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2008-09-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078643-001	AB
A078643-002	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	A078643-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078643-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078643-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078643-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078643-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078643-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078643-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078643-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078643-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078643-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078643-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078643-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078643-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078643-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078643-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078643-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078643-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078643-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078643-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078643-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078643-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-09-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078643-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078643-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-09-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078643-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078643-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-09-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078643-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078643-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-09-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078643-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078643-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-09-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078643-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078643-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-09-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078643-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078643-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-09-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078643-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078643-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-09-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078643-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078643-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-09-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078643-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078643-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2008-09-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078643-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2008-09-26	`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	A078643-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078643-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078643-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078643-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078643-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078643-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078643-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078643-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078643-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078643-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078643-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078643-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078643-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078643-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078643-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078643-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078643-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078643-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078643-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078643-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078643-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078643-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078643-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078643-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078643-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078643-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078643-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078643-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078643-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078643-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078643-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078643-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078643-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078643-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078643-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078643-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078643-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078643-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078643-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078643-002	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
1154688c-1383-442b-a3a5-ec01e038795c	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	SPL version
65862-191-01	Cyclobenzaprine Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	10
65862-191-05	Cyclobenzaprine Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	10
65862-191-99	Cyclobenzaprine Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-191-01	EA - Each	65862-191	b313eb09-33bd-4841-be73-ff2d8042d0cc	1	2012-07-24
65862-191-05	EA - Each	65862-191	a1af2712-5937-4b55-a9b1-e85daefea01e	1	2012-07-24
65862-191-99	EA - Each	65862-191	ba6b0a83-94e0-4e72-978d-bc9c89906958	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	7
CYCLOBENZAPRINE HYDROCHLORIDE	ACTIVE INGREDIENT	0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CYCLOBENZAPRINE	ACTIVE MOIETY	69O5WQQ5TI	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-191	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	10	Current NDC, Legacy NDC, 3 package rows	20211110_1154688c-1383-442b-a3a5-ec01e038795c.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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Major Pharmaceuticals	508e310e-067a-4f95-869a-e1da49aabe94	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078643 application number: ANDA078643
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Cardinal Health 107, LLC	df902d94-9d2b-4139-aebb-3eb6b8b8cd54	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078643 application number: ANDA078643
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	e4ed7ad2-cf58-4fdb-bc8c-d89f23b01210	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078643 application number: ANDA078643
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	b09ca979-ab6b-441b-a66f-41ca32eae6cb	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078643 application number: ANDA078643
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	014dd648-5b84-4d1d-80fc-a467e2d741ef	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078643 application number: ANDA078643
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	29ca9548-23b0-4c50-82cb-4f0564d7e065	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078643 application number: ANDA078643
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Northwind Health Company, LLC	1912d134-a909-5511-e063-6294a90aea29	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078643 application number: ANDA078643
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	QPharma Inc	fbe6ba88-0581-50ef-e053-6394a90ab086	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078643 application number: ANDA078643
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	cc93038f-1202-47f3-a959-2877877cc869	2025-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078643 application number: ANDA078643
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	e3b5fc92-9186-6944-e053-2a95a90a1c9f	2025-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078643 application number: ANDA078643
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Redpharm Drug	fc61c9f5-b0ec-3ff8-e053-6394a90adeb7	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078643 application number: ANDA078643
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Redpharm Drug	09d35c34-11fa-3a5d-e063-6294a90ab172	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078643 application number: ANDA078643
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	db49801d-9bde-5dd0-e053-2a95a90aee53	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078643 application number: ANDA078643
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	0a695685-cfec-464e-840c-32e3b7a68bd3	2024-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078643 application number: ANDA078643
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	193744c8-ff8e-4f65-aec1-1c13f471ac82	2024-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078643 application number: ANDA078643
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Medsource Pharmaceuticals	12645f19-fffc-8b08-e063-6394a90a5c55	2024-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078643 application number: ANDA078643
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	74af1727-e84f-4dad-82be-045e7d23beaf	2023-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078643 application number: ANDA078643
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	e3998083-e3db-4052-9b5b-19d7aaa4e658	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078643 application number: ANDA078643
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Aurobindo Pharma Limited	1154688c-1383-442b-a3a5-ec01e038795c	2021-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078643 application number: ANDA078643 ndc (product): 65862-191
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	0280b504-4a42-44f3-8a1a-34a20eac054a	2021-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078643 application number: ANDA078643

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	1154688c-1383-442b-a3a5-ec01e038795c	10
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	1154688c-1383-442b-a3a5-ec01e038795c	10
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	1154688c-1383-442b-a3a5-ec01e038795c	10
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	1154688c-1383-442b-a3a5-ec01e038795c	10
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	c62f6022-aafd-456e-b52c-99cd1cc5c3c6	1
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	c62f6022-aafd-456e-b52c-99cd1cc5c3c6	1
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	c62f6022-aafd-456e-b52c-99cd1cc5c3c6	1
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	c62f6022-aafd-456e-b52c-99cd1cc5c3c6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-191-01	65862019101	100 TABLET, FILM COATED in 1 BOTTLE (65862-191-01)	2008-09-26	0000-00-00	No	No	Current
65862-191-05	65862019105	500 TABLET, FILM COATED in 1 BOTTLE (65862-191-05)	2008-09-26	0000-00-00	No	No	Current
65862-191-81	65862019181	8000 TABLET, FILM COATED in 1 BAG (65862-191-81)	26-SEP-08				Current
65862-191-99	65862019199	1000 TABLET, FILM COATED in 1 BOTTLE (65862-191-99)	2008-09-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyclobenzaprine Hydrochloride Tablets, USP Rx only	Aurobindo Pharma Limited	2021-11-09	Human Prescription Drug Label	10
Cyclobenzaprine Hydrochloride Tablets, USP	State of Florida DOH Central Pharmacy	2013-09-09	HUMAN PRESCRIPTION DRUG LABEL	1