What is NDC 80425-0448?

80425-0448 is the product NDC for Tizanidine Hydrochloride, Tizanidine hydrochloride 6 mg/1 capsule, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 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 Hydrochloride?

54 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tizanidine Hydrochloride NDC 80425-0448

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0448Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0448Add 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
80425-0448-1	8042504480180425044801	30 CAPSULE in 1 BOTTLE, PLASTIC (80425-0448-1)Marketed from Oct 29, 2024
80425-0448-2	8042504480280425044802	60 CAPSULE in 1 BOTTLE, PLASTIC (80425-0448-2)Marketed from Oct 29, 2024
80425-0448-3	8042504480380425044803	90 CAPSULE in 1 BOTTLE, PLASTIC (80425-0448-3)Marketed from Oct 29, 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 Hydrochloride
Generic name (nonproprietary): tizanidine hydrochloride
Active ingredients: Tizanidine hydrochloride — 6 mg/1
Dosage form: Capsule
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 210267
Marketing start: Oct 29, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 80425-0448_26f91e07-2e12-1faf-e063-6394a90a0eb4SPL ID 26f91e07-2e12-1faf-e063-6394a90a0eb4SPL set ID 26f8f233-5dc2-0013-e063-6394a90ab0f5RxCUI 485484UNII 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

N480425044801 followed by a unit qualifier and the quantity

Package 80425-0448-01. 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 Oct 29, 2024.

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0448

What is NDC 80425-0448?: 80425-0448 is the product NDC for Tizanidine Hydrochloride, Tizanidine hydrochloride 6 mg/1 capsule, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tizanidine Hydrochloride.
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 Hydrochloride?: 54 other product NDCs are listed under this name. See all Tizanidine Hydrochloride 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 Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tizanidine Hydrochloride	Tizanidine hydrochloride 8 mg/1	CapsuleOral	Trifluent Pharma, LLC	73352-089	73352-0089-60
tizanidine hydrochloride	Tizanidine hydrochloride 8 mg/1	CapsuleOral	Advagen Pharma Limited	72888-161	72888-0161-15
tizanidine hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Advanced Rx of Tennessee, LLC	80425-0474	80425-0474-0180425-0474-0280425-0474-03+1 more
tizanidine hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-8776	68788-8776-0168788-8776-0268788-8776-03+3 more
Tizanidine Hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-8747	68788-8747-0168788-8747-0268788-8747-03+3 more
Tizanidine Hydrochloride	Tizanidine hydrochloride 6 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-8478	68788-8478-0168788-8478-0368788-8478-06+1 more
tizanidine hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2559	71335-2559-0171335-2559-0271335-2559-03+1 more
tizanidine hydrochloride	Tizanidine hydrochloride 6 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2872	71335-2872-0171335-2872-0271335-2872-03+2 more
tizanidine hydrochloride	Tizanidine hydrochloride 6 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	72789-505	72789-0505-77
tizanidine hydrochloride	Tizanidine hydrochloride 2 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	72789-506	72789-0506-77

All 55 Tizanidine Hydrochloride NDCs

Other NDCs under ANDA 210267

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

FDA NDC Directory listings under ANDA 210267
Product	Strength	Form · route	Labeler	Product NDC
Tizanidine	Tizanidine hydrochloride 6 mg/1	CapsuleOral	Direct_Rx	72189-526
Tizanidine HCL	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Advanced Rx of Tennessee, LLC	80425-0090
Tizanidine Hydrochloride	Tizanidine hydrochloride 2 mg/1	CapsuleOral	Ingenus Pharmaceuticals, LLC	50742-224
Tizanidine Hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Ingenus Pharmaceuticals, LLC	50742-225
Tizanidine Hydrochloride	Tizanidine hydrochloride 6 mg/1	CapsuleOral	Ingenus Pharmaceuticals, LLC	50742-226
Tizanidine Hydrochloride	Tizanidine hydrochloride 6 mg/1	CapsuleOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-892
Tizanidine Hydrochloride	Tizanidine hydrochloride 6 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-8478
Tizanidine Hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-8747
Tizanidine Hydrochloride	Tizanidine hydrochloride 6 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-9743