NDC 80425-0018-01 - Cyclobenzaprine HCL

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 80425-0018
Requested NDC: 80425-0018-01
Package NDCs from labels: 80425-0018-2, 80425-0018-3, 80425-0018-1, 80425-0018-01
Manufacturer: Advanced Rx of Tennessee, LLC
Effective date: 2024-12-31
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Cyclobenzaprine HCL - Advanced Rx of Tennessee, LLC	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80425-0018-1	Cyclobenzaprine HCL	30 in 1 BOTTLE	TABLET, FILM COATED	30	8
80425-0018-2	Cyclobenzaprine HCL	60 in 1 BOTTLE	TABLET, FILM COATED	60	8
80425-0018-3	Cyclobenzaprine HCL	90 in 1 BOTTLE	TABLET, FILM COATED	90	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0018	CYCLOBENZAPRINE HCL TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]	8	Current NDC, Legacy NDC, 3 package rows	20250101_afcab35f-4ab9-33a4-e053-2a95a90ad529.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0018-1	EA - Each	80425-0018	4b64f1c0-c241-4839-b0e1-a721173296d8	1	2023-03-13
80425-0018-2	EA - Each	80425-0018	0b1b8bdf-7a8d-4901-b71b-da92a9ceb5d0	1	2023-03-13
80425-0018-3	EA - Each	80425-0018	71405b22-828e-47c4-939a-69cdf17fde83	1	2023-03-13

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 9 of 10 · 188 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	34ff8a08-0177-451f-9dbc-e21582346196	2024-01-01	Warnings, Adverse reactions	Exact identifier application number: ANDA208170 rxcui: 828320 unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	31bb92f6-ec8c-4636-8b07-8814417fe78e	2023-12-31	Warnings, Adverse reactions	Exact identifier rxcui: 828320 rxcui: 828348 unii: 0VE05JYS2P
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	4a2d3cae-5c64-4986-9707-cc213b70b7ad	2023-10-19	Warnings, Adverse reactions	Exact identifier rxcui: 828348 unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	85128989-bfa3-4b82-94c1-f90b14ccd2f9	2023-10-18	Warnings, Adverse reactions	Exact identifier application number: ANDA208170 rxcui: 828320 rxcui: 828348 unii: 0VE05JYS2P
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	74af1727-e84f-4dad-82be-045e7d23beaf	2023-09-06	Warnings, Adverse reactions	Exact identifier rxcui: 828348 unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	88bdee56-d6d9-4f14-be77-1e6898ba36f5	2023-09-01	Warnings, Adverse reactions	Exact identifier application number: ANDA208170 rxcui: 828348 unii: 0VE05JYS2P
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Bryant Ranch Prepack	6ebaccfc-f57c-4547-ade0-6a6e204f5ea0	2023-03-27	Warnings, Adverse reactions	Exact identifier rxcui: 828320 unii: 0VE05JYS2P
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	68db3c3b-8da1-4852-90b0-3172f842aa02	2023-03-02	Warnings, Adverse reactions	Exact identifier rxcui: 828348 unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	A-S Medication Solutions	b524d150-0a83-42d1-a884-b930e49760cd	2023-02-06	Warnings, Adverse reactions	Exact identifier application number: ANDA208170 rxcui: 828348 unii: 0VE05JYS2P
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	1adcdd8a-30f9-4a7b-853c-948a5589acab	2023-01-03	Warnings, Adverse reactions	Exact identifier rxcui: 828299 rxcui: 828320 rxcui: 828348 unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	2a6b2ad9-307a-4976-98b7-1b96e0408da7	2022-09-14	Warnings, Adverse reactions	Exact identifier application number: ANDA208170 rxcui: 828299 unii: 0VE05JYS2P
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	f8dec4e2-3151-4a79-b194-a11a57ada0b6	2022-09-03	Warnings, Adverse reactions	Exact identifier rxcui: 828299 rxcui: 828320 rxcui: 828348 unii: 0VE05JYS2P
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Solco Healthcare U.S., LLC	f558863b-ea3f-4e4b-85e9-edb2573e7151	2022-08-22	Warnings, Adverse reactions	Exact identifier rxcui: 828320 rxcui: 828348 unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	751f0d33-ceff-40b0-9329-9125f176e06a	2022-07-29	Warnings, Adverse reactions	Exact identifier application number: ANDA208170 rxcui: 828320 unii: 0VE05JYS2P
Cyclobenzaprine hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Asclemed USA, Inc.	59945ea1-8136-4014-acd9-cdfe6e11e8da	2022-07-19	Warnings, Adverse reactions	Exact identifier rxcui: 828299 unii: 0VE05JYS2P
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	e3998083-e3db-4052-9b5b-19d7aaa4e658	2022-07-01	Warnings, Adverse reactions	Exact identifier rxcui: 828320 unii: 0VE05JYS2P
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	d8112916-28ae-452c-8ec8-a4972e5f549b	2022-05-02	Warnings, Adverse reactions	Exact identifier unii: 0VE05JYS2P
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE HYDROCHLORIDE	Proficient Rx LP	ffd82a69-a64c-4399-8f5d-bddc70cdc3cf	2022-05-01	Warnings, Adverse reactions	Exact identifier unii: 0VE05JYS2P
Cyclobenzaprine Hydrochloride	CYCLOBENZAPRINE	Proficient Rx LP	ae6de8d8-33c2-40bd-9dd3-782c879a9d8f	2022-04-01	Warnings, Adverse reactions	Exact identifier rxcui: 828348 unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDE	CYCLOBENZAPRINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	3cdde96c-9fc9-4698-872a-25c05318ecb5	2021-11-19	Warnings, Adverse reactions	Exact identifier rxcui: 828299 rxcui: 828320 rxcui: 828348 unii: 0VE05JYS2P

Reported adverse events (FAERS/openFDA)#

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