What is NDC 71610-776?

71610-776 is the product NDC for tizanidine, Tizanidine hydrochloride 4 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 7 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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?

110 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 71610-776 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-776Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0776Add 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
71610-776-16	7161007761671610077616	6000 TABLET in 1 BOTTLE (71610-776-16)Marketed from Jan 25, 2024
71610-776-30	7161007763071610077630	30 TABLET in 1 BOTTLE (71610-776-30)Marketed from Jan 22, 2024
71610-776-53	7161007765371610077653	60 TABLET in 1 BOTTLE (71610-776-53)Marketed from Jan 25, 2024
71610-776-60	7161007766071610077660	90 TABLET in 1 BOTTLE (71610-776-60)Marketed from Jan 25, 2024
71610-776-70	7161007767071610077670	120 TABLET in 1 BOTTLE (71610-776-70)Marketed from Jan 24, 2025
71610-776-75	7161007767571610077675	7500 TABLET in 1 BOTTLE (71610-776-75)Marketed from Apr 1, 2024
71610-776-80	7161007768071610077680	180 TABLET in 1 BOTTLE (71610-776-80)Marketed from Jan 24, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076533
Marketing start: Jan 16, 2004
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 71610-776_2cee3817-e6f6-9db6-e063-6294a90a6ea1SPL ID 2cee3817-e6f6-9db6-e063-6294a90a6ea1SPL set ID ef7673f4-e0c1-4d79-af36-2f2ed2cc28f7RxCUI 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

N471610077616 followed by a unit qualifier and the quantity

Package 71610-0776-16. 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 29, 2025.

Indications (excerpt from the label)

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) ]. 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. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-776

What is NDC 71610-776?: 71610-776 is the product NDC for tizanidine, Tizanidine hydrochloride 4 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 7 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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?: 110 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 111 tizanidine NDCs

Other NDCs under ANDA 076533

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

FDA NDC Directory listings under ANDA 076533
Product	Strength	Form · route	Labeler	Product NDC
tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Major Pharmaceuticals	0904-6418
tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Cardinal Health 107, LLC	55154-7287
tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Apotex Corp.	60505-0251
tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Apotex Corp.	60505-0252
tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Proficient Rx LP	63187-145
tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8741
tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-455