NDC 80425-0022-01 - Tizanidine 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: 80425-0022
Requested NDC: 80425-0022-01
Package NDCs from labels: 80425-0022-2, 80425-0022-1, 80425-0022-01
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
Tizanidine 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	Strength	SPL version
80425-0022-1	Tizanidine HCL	60 in 1 BOTTLE	TABLET	60		6
80425-0022-2	Tizanidine HCL	90 in 1 BOTTLE	TABLET	90		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0022	TIZANIDINE HCL TABLET [ADVANCED RX OF TENNESSEE, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20250101_af73c6ab-6c1c-94d1-e053-2a95a90a4e3c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0022-1	EA - Each	80425-0022	add5c82f-6c8a-48e1-84a7-707cd9bc8ff8	1	2023-06-06
80425-0022-2	EA - Each	80425-0022	6e887858-2ea9-4fb2-aec2-2d39608f5381	1	2023-06-06

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 7 of 7 · 127 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tizanidine	TIZANIDINE	Proficient Rx LP	76dc85bd-3cde-4940-a99b-663b70bf9f54	2022-03-01	Warnings, Adverse reactions	Exact identifier application number: ANDA076416 rxcui: 313413 unii: B53E3NMY5C
Tizanidine	TIZANIDINE	Bryant Ranch Prepack	b254a0f4-efb1-4874-ae45-1dc5fe316964	2021-12-27	Warnings, Adverse reactions	Exact identifier rxcui: 313413 unii: B53E3NMY5C
Tizanidine	TIZANIDINE	Bryant Ranch Prepack	82084f4e-00d0-c298-c13a-88a6c0860b02	2021-12-08	Warnings, Adverse reactions	Exact identifier rxcui: 313412 unii: B53E3NMY5C
Tizanidine	TIZANIDINE	Proficient Rx LP	20424d92-5ca1-4114-bc51-1f07c3bed6be	2021-03-01	Warnings, Adverse reactions	Exact identifier application number: ANDA076416 rxcui: 313412 unii: B53E3NMY5C
Tizanidine	TIZANIDINE	Sun Pharmaceutical Industries, Inc.	4659df31-8b89-4eff-9d86-7b7e38de416b	2020-10-09	Warnings, Adverse reactions	Exact identifier application number: ANDA076416 ndc (product): 57664-503 rxcui: 313412 rxcui: 313413 spl id: 5e8ef5b3-9f58-46a7-833c-31ef018ea9a0 spl set id: 4659df31-8b89-4eff-9d86-7b7e38de416b unii: B53E3NMY5C
tizanidine	TIZANIDINE	Aphena Pharma Solutions - Tennessee, LLC	d3b8d863-d13d-467c-97bf-5db9708036db	2020-08-28	Warnings, Adverse reactions	Exact identifier rxcui: 313412 unii: B53E3NMY5C
Tizanidine	TIZANIDINE	Aphena Pharma Solutions - Tennessee, LLC	ea242c7d-b101-4197-8e65-b2b079e3b2b6	2019-02-11	Warnings, Adverse reactions	Exact identifier rxcui: 313413 unii: B53E3NMY5C

Reported adverse events (FAERS/openFDA)#

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