What is NDC 80425-0453?

80425-0453 is the product NDC for Tizanidine, Tizanidine hydrochloride 4 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tizanidine?

111 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tizanidine NDC 80425-0453 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0453Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0453Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
80425-0453-1	8042504530180425045301	30 TABLET in 1 BOTTLE (80425-0453-1)Marketed from Nov 22, 2024
80425-0453-2	8042504530280425045302	60 TABLET in 1 BOTTLE (80425-0453-2)Marketed from Nov 22, 2024
80425-0453-3	8042504530380425045303	90 TABLET in 1 BOTTLE (80425-0453-3)Marketed from Nov 22, 2024
80425-0453-4	8042504530480425045304	120 TABLET in 1 BOTTLE (80425-0453-4)Marketed from Nov 22, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Tizanidine
Generic name (nonproprietary): tizanidine
Active ingredients: Tizanidine hydrochloride — 4 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208187
Marketing start: Nov 22, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 80425-0453_2aabf642-2907-a735-e063-6394a90a83b5SPL ID 2aabf642-2907-a735-e063-6394a90a83b5SPL set ID 21b7c8a8-ee07-a204-e063-6394a90a285bRxCUI 313412, 313413UNII B53E3NMY5C
Pharmacologic class: Central alpha-2 Adrenergic Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N480425045301 followed by a unit qualifier and the quantity

Package 80425-0453-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 1, 2025.

Indications (excerpt from the label)

Tizanidine tablets are a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine tablets should be reserved for those daily activities and times when relief of spasticity is most important. ( 1 ) Tizanidine tablets are indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine tablets should be reserved for those daily activities and times when relief of spasticity is most important [ see Dosage and Administration (2.1) ] .

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0453

What is NDC 80425-0453?: 80425-0453 is the product NDC for Tizanidine, Tizanidine hydrochloride 4 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tizanidine.
What is the active ingredient?: Tizanidine hydrochloride.
Who is the labeler?: Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tizanidine?: 111 other product NDCs are listed under this name. See all Tizanidine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tizanidine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Aurobindo Pharma Limited	84386-023	84386-0023-7784386-0023-99
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Aurobindo Pharma Limited	84386-024	84386-0024-7784386-0024-99
tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4159	68788-4159-0168788-4159-0268788-4159-03+3 more
Tizanidine	Tizanidine hydrochloride 6 mg/1	CapsuleOral	Direct_Rx	72189-678	72189-0678-30
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Medcore LLC	82461-720	82461-0720-60
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Medcore LLC	82461-721	82461-0721-60
tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0500	80425-0500-0180425-0500-0280425-0500-03
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8802	68788-8802-0168788-8802-0268788-8802-03+3 more
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Direct_rx	72189-602	72189-0602-3072189-0602-6072189-0602-90
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Direct_rx	72189-599	72189-0599-3072189-0599-6072189-0599-82+1 more

All 112 Tizanidine NDCs

Other NDCs under ANDA 208187

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 208187
Product	Strength	Form · route	Labeler	Product NDC
tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8468
tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8469
tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Coupler LLC	67046-1444
tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3719
tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	REMEDYREPACK INC.	70518-4181
tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1335
tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1336
tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-096
tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-097
tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Asclemed USA, Inc.	76420-885
tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Asclemed USA, Inc.	76420-886
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0436
tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0454
tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0500