What is NDC 68071-3719?

68071-3719 is the product NDC for tizanidine, Tizanidine hydrochloride 4 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

NuCare Pharmaceuticals, Inc., NDC labeler code 68071. 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 68071-3719 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-3719Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-3719Add 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	Copy
68071-3719-3	6807137190368071371903	30 TABLET in 1 BOTTLE (68071-3719-3)Marketed from Nov 13, 2024
68071-3719-9	6807137190968071371909	90 TABLET in 1 BOTTLE (68071-3719-9)Marketed from Jan 14, 2025

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: NuCare Pharmaceuticals, Inc.NDC labeler code 68071
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208187
Marketing start: Mar 4, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 68071-3719_2bae2620-0abb-7e55-e063-6394a90ad47cSPL ID 2bae2620-0abb-7e55-e063-6394a90ad47cSPL set ID 26cffb1f-21a0-017f-e063-6394a90afb1aRxCUI 313413UNII B53E3NMY5CUPC 0368071371932
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

N468071371903 followed by a unit qualifier and the quantity

Package 68071-3719-03. 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 14, 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 68071-3719

What is NDC 68071-3719?: 68071-3719 is the product NDC for tizanidine, Tizanidine hydrochloride 4 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals, Inc.. It has 2 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?: NuCare Pharmaceuticals, Inc., NDC labeler code 68071. 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 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	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	80425-0453
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