What is NDC 80425-0024?

80425-0024 is the product NDC for Tizanidine HCL, 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 HCL?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tizanidine HCL NDC 80425-0024 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0024Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0024Add 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
80425-0024-1	8042500240180425002401	60 TABLET in 1 BOTTLE (80425-0024-1)Marketed from Apr 1, 2013
80425-0024-2	8042500240280425002402	90 TABLET in 1 BOTTLE (80425-0024-2)Marketed from Apr 1, 2013
80425-0024-3	8042500240380425002403	30 TABLET in 1 BOTTLE (80425-0024-3)Marketed from Apr 1, 2013
80425-0024-4	8042500240480425002404	120 TABLET in 1 BOTTLE (80425-0024-4)Marketed from Mar 31, 2023

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 HCL
Generic name (nonproprietary): tizanidine hcl
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 091283
Marketing start: Apr 1, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 80425-0024_2a984dd9-7291-77f0-e063-6294a90a8f1eSPL ID 2a984dd9-7291-77f0-e063-6294a90a8f1eSPL set ID afc96ee6-c99b-7283-e053-2a95a90ad14dRxCUI 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

N480425002401 followed by a unit qualifier and the quantity

Package 80425-0024-01. 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 Dec 31, 2024.

Indications (excerpt from the label)

1. Indications and Usage Section 1 INDICATIONS AND USAGE Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine 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 80425-0024

What is NDC 80425-0024?: 80425-0024 is the product NDC for Tizanidine HCL, 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 HCL.
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 HCL?: 5 other product NDCs are listed under this name. See all Tizanidine HCL 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 HCL NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tizanidine HCl	Tizanidine hydrochloride 2 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0425	80425-0425-0180425-0425-0280425-0425-03
Tizanidine HCL	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0144	80425-0144-0180425-0144-0280425-0144-03+1 more
Tizanidine HCL	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Advanced Rx of Tennessee, LLC	80425-0090	80425-0090-0180425-0090-0280425-0090-03+1 more
Tizanidine HCL	Tizanidine hydrochloride 4 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0022	80425-0022-0180425-0022-02
Tizanidine HCl	Tizanidine hydrochloride 4 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0023	80425-0023-0180425-0023-0280425-0023-03+1 more

Other NDCs under ANDA 091283

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

FDA NDC Directory listings under ANDA 091283
Product	Strength	Form · route	Labeler	Product NDC
Tizandine	Tizanidine hydrochloride 2 mg/1	TabletOral	Direct_Rx	61919-811
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	29300-168
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Unichem Pharmaceuticals (USA), Inc.	29300-169
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-868
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	A-S Medication Solutions	50090-2078
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	A-S Medication Solutions	50090-5767
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	A-S Medication Solutions	50090-7889
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Proficient Rx LP	63187-493
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Proficient Rx LP	63187-910
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Redpharm Drug	67296-2209
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4463
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8802
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	REMEDYREPACK INC.	70518-1598
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Bryant Ranch Prepack	71335-0424
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Bryant Ranch Prepack	71335-0914
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-228
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0187
Tizanidine Hydrochloride	Tizanidine hydrochloride 4 mg/1	TabletOral	TIZANIDINE HYDROCHLORIDE	61919-196