What is NDC 76420-866?

76420-866 is the product NDC for Tizanidine, Tizanidine hydrochloride 4 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.

Asclemed USA, Inc., NDC labeler code 76420. 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 76420-866 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-866Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0866Add 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
76420-866-00	7642008660076420086600	1000 TABLET in 1 BOTTLE (76420-866-00)Marketed from Oct 29, 2024
76420-866-12	7642008661276420086612	120 TABLET in 1 BOTTLE (76420-866-12)Marketed from Oct 29, 2024
76420-866-15	7642008661576420086615	150 TABLET in 1 BOTTLE (76420-866-15)Marketed from Oct 29, 2024
76420-866-30	7642008663076420086630	30 TABLET in 1 BOTTLE (76420-866-30)Marketed from Oct 29, 2024
76420-866-60	7642008666076420086660	60 TABLET in 1 BOTTLE (76420-866-60)Marketed from Oct 29, 2024
76420-866-90	7642008669076420086690	90 TABLET in 1 BOTTLE (76420-866-90)Marketed from Oct 29, 2024

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: Asclemed USA, Inc.NDC labeler code 76420
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076286
Marketing start: Jun 15, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 76420-866_259ac6fd-2a83-04c0-e063-6394a90af566SPL ID 259ac6fd-2a83-04c0-e063-6394a90af566SPL set ID 81385ce2-1d82-4987-8e18-83c823e10b99RxCUI 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

N476420086600 followed by a unit qualifier and the quantity

Package 76420-0866-00. 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 tablet is 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 [see Dosage and Administration ( 2.1 ) ]. Tizanidine tablet is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine tablet 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 76420-866

What is NDC 76420-866?: 76420-866 is the product NDC for Tizanidine, Tizanidine hydrochloride 4 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 6 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?: Asclemed USA, Inc., NDC labeler code 76420. 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 076286

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

FDA NDC Directory listings under ANDA 076286
Product	Strength	Form · route	Labeler	Product NDC
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	NorthStar Rx LLC	16714-171
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	NorthStar Rx LLC	16714-172
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Quality Care Products, LLC	35356-662
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-455
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	A-S Medication Solutions	50090-0811
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	A-S Medication Solutions	50090-0840
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	A-S Medication Solutions	50090-6756
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	A-S Medication Solutions	50090-6757
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	AvPAK	50268-759
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	AvPAK	50268-760
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Northwind Health Company, LLC	51655-603
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Dr. Reddy's Laboratories Limited	55111-179
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Dr. Reddy's Laboratories Limited	55111-180
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-505
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-694
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Proficient Rx LP	63187-009
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Bryant Ranch Prepack	63629-1673
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Bryant Ranch Prepack	63629-3209
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Redpharm Drug	67296-2263
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Redpharm Drug	67296-2316

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