Cyclobenzaprine Hydrochloride

Product NDC: 69097-846
11-digit product format: 690970846
Labeler code: 69097
Product ID: 69097-846_0e5c376d-9599-4825-9226-016d40cf6113
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclobenzaprine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Cipla USA Inc.
Application: ANDA090478
Marketing category: ANDA
Marketing start: 2016-07-22
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

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
A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2010-07-23
A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2010-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090478-001	AB
A090478-002	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	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090478-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2010-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090478-002	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2010-07-23	`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	A090478-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090478-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090478-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090478-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090478-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090478-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090478-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090478-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090478-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090478-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090478-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090478-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090478-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090478-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090478-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090478-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090478-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090478-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090478-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090478-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090478-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090478-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090478-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090478-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090478-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090478-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090478-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090478-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090478-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090478-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090478-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090478-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090478-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090478-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090478-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090478-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090478-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090478-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090478-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090478-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cyclobenzaprine Hydrochloride
Listing expiration: 2027-12-31

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
575a31fb-04c5-4001-88a7-c33adbacc6a8	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
69097-846-07	Cyclobenzaprine Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100		4
69097-846-15	Cyclobenzaprine Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-846	CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE) TABLET, FILM COATED [CIPLA USA INC.]	4	Current NDC, Legacy NDC, 2 package rows	20210316_575a31fb-04c5-4001-88a7-c33adbacc6a8.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	Cipla USA Inc.	575a31fb-04c5-4001-88a7-c33adbacc6a8	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478 ndc (product): 69097-846
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	NuCare Pharmaceuticals, Inc.	4fbbc5b6-7aac-34e5-e054-00144ff88e88	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	NuCare Pharmaceuticals, Inc.	4a2b5f25-a333-15f3-e054-00144ff8d46c	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	Northwind Health Company, LLC	e04eea45-12ec-4d2b-e053-2a95a90a6b76	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	American Health Packaging	269bc278-963d-4830-816a-39bb4bf8c936	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	AvPAK	64f6d1be-4067-a5c7-2343-4aed651a0cac	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	AvPAK	e530fd1e-06fd-0432-e053-2995a90adf5f	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	Aphena Pharma Solutions - Tennessee, LLC	3bc7e2b4-e1a0-66e3-e063-6294a90a676a	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	EXELAN PHARMACEUTICALS, INC.	cf81da00-7c6d-4477-bb70-b3c2abea177a	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	NCS HealthCare of KY, LLC dba Vangard Labs	53688de9-2031-4d19-b422-4000285f7f47	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	Proficient Rx LP	ae6de8d8-33c2-40bd-9dd3-782c879a9d8f	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090478 application number: ANDA090478

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE	6202-23-9	CYCLOBENZAPRINE HYDROCHLORIDE
69O5WQQ5TI	CYCLOBENZAPRINE	303-53-7	Cyclobenzaprine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	ae6de8d8-33c2-40bd-9dd3-782c879a9d8f	9
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	ae6de8d8-33c2-40bd-9dd3-782c879a9d8f	9
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	4a2b5f25-a333-15f3-e054-00144ff8d46c	7
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	4a2b5f25-a333-15f3-e054-00144ff8d46c	7
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	53688de9-2031-4d19-b422-4000285f7f47	6
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	53688de9-2031-4d19-b422-4000285f7f47	6
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	2ff7cb40-9b43-47fb-a7b4-f9e6e9d65e5b	5
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	77f5c98e-9196-31d6-e053-2a91aa0a5205	5
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	4fbbc5b6-7aac-34e5-e054-00144ff88e88	5
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	50c28fda-7d64-08ce-e054-00144ff8d46c	5
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	2ff7cb40-9b43-47fb-a7b4-f9e6e9d65e5b	5
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	77f5c98e-9196-31d6-e053-2a91aa0a5205	5
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	4fbbc5b6-7aac-34e5-e054-00144ff88e88	5
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	50c28fda-7d64-08ce-e054-00144ff8d46c	5
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	f4432fc3-ec30-46c6-84aa-19dcf59dfe91	4
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	575a31fb-04c5-4001-88a7-c33adbacc6a8	4
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	269bc278-963d-4830-816a-39bb4bf8c936	4
828320	cyclobenzaprine HCl 5 MG Oral Tablet	PSN	575a31fb-04c5-4001-88a7-c33adbacc6a8	4
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	575a31fb-04c5-4001-88a7-c33adbacc6a8	4
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	f4432fc3-ec30-46c6-84aa-19dcf59dfe91	4
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	269bc278-963d-4830-816a-39bb4bf8c936	4
828320	cyclobenzaprine hydrochloride 5 MG Oral Tablet	SCD	575a31fb-04c5-4001-88a7-c33adbacc6a8	4
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	4deda6bd-60ff-1690-e054-00144ff8d46c	3
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	41709710-5397-3119-e054-00144ff88e88	3
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	c519e446-fa50-487d-a54d-fc3bfdd7d034	3
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	e04eea45-12ec-4d2b-e053-2a95a90a6b76	3
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	e530fd1e-06fd-0432-e053-2995a90adf5f	3
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	4deda6bd-60ff-1690-e054-00144ff8d46c	3
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	41709710-5397-3119-e054-00144ff88e88	3
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	c519e446-fa50-487d-a54d-fc3bfdd7d034	3
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	e04eea45-12ec-4d2b-e053-2a95a90a6b76	3
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	e530fd1e-06fd-0432-e053-2995a90adf5f	3
828348	cyclobenzaprine HCl 10 MG Oral Tablet	PSN	252fb808-90a7-47a5-8557-bf4a8d8c4118	1
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	252fb808-90a7-47a5-8557-bf4a8d8c4118	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69097-846-07	69097084607	100 TABLET, FILM COATED in 1 BOTTLE (69097-846-07)	2016-07-22	0000-00-00	No	No	Current
69097-846-15	69097084615	1000 TABLET, FILM COATED in 1 BOTTLE (69097-846-15)	2016-07-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CYCLOBENZAPRINE HCl TABLETS USP	Cipla USA Inc. \| InvaGen Pharmaceutical Inc	2026-07-08	HUMAN PRESCRIPTION DRUG LABEL	5
CYCLOBENZAPRINE HCl TABLETS USP	NuCare Pharmaceuticals, Inc.	2026-05-19	HUMAN PRESCRIPTION DRUG LABEL	5
CYCLOBENZAPRINE HCl TABLETS USP	NuCare Pharmaceuticals, Inc.	2026-05-05	HUMAN PRESCRIPTION DRUG LABEL	7
CYCLOBENZAPRINE HCl TABLETS USP	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Cyclobenzaprine Hydrochloride Tablets USP 8455801/0224 Rx Only	American Health Packaging	2025-11-13	HUMAN PRESCRIPTION DRUG LABEL	4
Cyclobenzaprine Hydrochloride Tablet USP Rx Only	AvPAK	2025-10-28	HUMAN PRESCRIPTION DRUG LABEL	3
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP	NCS HealthCare of KY, LLC dba Vangard Labs	2024-08-12	HUMAN PRESCRIPTION DRUG LABEL	7
CYCLOBENZAPRINE HCl TABLETS USP	Preferred Pharmaceuticals Inc.	2024-03-15	HUMAN PRESCRIPTION DRUG LABEL	1
CYCLOBENZAPRINE HCl TABLETS USP	REMEDYREPACK INC.	2024-01-03	HUMAN PRESCRIPTION DRUG LABEL	16
CYCLOBENZAPRINE HCl TABLETS USP	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
CYCLOBENZAPRINE HCl TABLETS USP	UNIT DOSE SERVICES	2023-04-19	HUMAN PRESCRIPTION DRUG LABEL	1
CYCLOBENZAPRINE HCl TABLETS USP	REMEDYREPACK INC.	2023-03-17	HUMAN PRESCRIPTION DRUG LABEL	3
CYCLOBENZAPRINE HCl TABLETS USP	REMEDYREPACK INC.	2022-06-22	HUMAN PRESCRIPTION DRUG LABEL	14
CYCLOBENZAPRINE HCl TABLETS USP	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	9
Cyclobenzaprine 10mg tabs	RedPharm Drug, Inc.	2022-01-21	HUMAN PRESCRIPTION DRUG LABEL	5
CYCLOBENZAPRINE HCl TABLETS USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-11	HUMAN PRESCRIPTION DRUG LABEL	5
CYCLOBENZAPRINE HCl TABLETS USP	Clinical Solutions Wholesale, LLC	2020-09-25	HUMAN PRESCRIPTION DRUG LABEL	4
CYCLOBENZAPRINE HCl TABLETS USP	Preferred Pharmaceuticals Inc.	2020-04-29	HUMAN PRESCRIPTION DRUG LABEL	7
CYCLOBENZAPRINE HYDROCHLORIDE	DIRECT RX	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	3
CYCLOBENZAPRINE HCl TABLETS USP	Legacy Pharmaceutical Packaging, LLC	2019-02-15	HUMAN PRESCRIPTION DRUG LABEL	5
148 Cyclobenzaprine 10 mg CYCLOBENZAPRINE HCl TABLETS USP	Coupler Enterprises	2018-12-19	HUMAN PRESCRIPTION DRUG LABEL	3
CYCLOBENZAPRINE HCl TABLETS USP	Virtue Rx, LLC	2018-02-28	HUMAN PRESCRIPTION DRUG LABEL	3