CYCLOBENZAPRINE HYDROCHLORIDE

Product NDC: 70518-3415
Requested package NDC: 70518-3415-1
11-digit product format: 705183415
Labeler code: 70518
Product ID: 70518-3415_4f06e16a-e75e-e39d-e063-6394a90a120a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cyclobenzaprine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA208170
Marketing category: ANDA
Marketing start: 2022-04-29
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: 2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31
A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31
A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A208170-001	AB
A208170-002	AB
A208170-003	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 4 · 123 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	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208170-002	CYCLOBENZAPRINE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB		2017-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208170-003	CYCLOBENZAPRINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2017-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208170-001	CYCLOBENZAPRINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-05-31	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A208170-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208170-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208170-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208170-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208170-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208170-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208170-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208170-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208170-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208170-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208170-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208170-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208170-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208170-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208170-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208170-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208170-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208170-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208170-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208170-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208170-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208170-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208170-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208170-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208170-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208170-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208170-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208170-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208170-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208170-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208170-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208170-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208170-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208170-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208170-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208170-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208170-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208170-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208170-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208170-001	AB	1	`8072bd15b7f6…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
8bef97d4-1b92-4316-8733-7751d627230f	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
70518-3415-0	CYCLOBENZAPRINE HYDROCHLORIDE	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	14
70518-3415-1	CYCLOBENZAPRINE HYDROCHLORIDE	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	14
70518-3415-2	CYCLOBENZAPRINE HYDROCHLORIDE	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	14
70518-3415-3	CYCLOBENZAPRINE HYDROCHLORIDE	12 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	12	14
70518-3415-4	CYCLOBENZAPRINE HYDROCHLORIDE	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	14
70518-3415-5	CYCLOBENZAPRINE HYDROCHLORIDE	14 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	14	14
70518-3415-6	CYCLOBENZAPRINE HYDROCHLORIDE	20 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	20	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70518-3415-1	EA - Each	70518-3415	1e21b7e3-d341-414e-ac64-523a753470b2	1	2026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3415	CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]	8	Current NDC, Legacy NDC, 7 package rows	20240926_8bef97d4-1b92-4316-8733-7751d627230f.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 3 · 57 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	f2eb32c3-3da0-4938-9ed9-ea8420450fde	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	TruPharma LLC	08adc97f-feef-46fb-ac75-f015b4f3a43a	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4ee4feec-4590-fa7f-e063-6394a90a5550	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	HAWAII REPACK, INC.	cf5d4de9-79c3-4935-be69-89e98d7b54cc	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	dfe7288c-a477-4f32-a9ab-00cc981a1a57	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	5d536e88-62be-45bd-bd09-0efc53fe12b9	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	53bef1ab-55c0-cc52-e063-6394a90a12b3	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	fe81c68d-a579-4fe9-e053-6294a90a7bc0	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	00b20a8c-debd-e930-e063-6394a90a7ed0	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Coupler LLC	5023b8a5-c9df-84a4-e063-6294a90a9606	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	QPharma, Inc.	4dcbdf8f-37ce-0f90-e063-6394a90ae83c	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	REMEDYREPACK INC.	8bef97d4-1b92-4316-8733-7751d627230f	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170 ndc (package): 70518-3415-1 ndc (product): 70518-3415 ndc11 (package): 70518341501
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	2f89c8f6-7f3c-8396-e063-6294a90a643e	2026-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Sportpharm LLC	24653b10-bdf0-47c5-a1f4-dc25f3b86032	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e4e8bab3-c5e7-4d2b-9692-ee6c6799b120	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e343fd12-1ca2-418a-b690-f3e8f567596d	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Direct_Rx	15aad4af-5c05-be36-e063-6294a90a9bb3	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4c3a3b4f-7b2b-3fe9-e063-6394a90aae47	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	dc3cc6b6-c692-4986-8ff7-3a6cd8c85cb2	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	06da53af-5b46-4e32-a64c-9677e27ae229	2026-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208170 application number: ANDA208170

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	8bef97d4-1b92-4316-8733-7751d627230f	14
828348	cyclobenzaprine hydrochloride 10 MG Oral Tablet	SCD	8bef97d4-1b92-4316-8733-7751d627230f	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70518-3415-1	70518341501	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3415-1)	2024-04-30	No	No	Current