What is NDC 71335-1016?

71335-1016 is the product NDC for Tizanidine, Tizanidine hydrochloride 4 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 71335. 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 71335-1016 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-1016Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-1016Add 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
71335-1016-0	7133510160071335101600	112 TABLET in 1 BOTTLE (71335-1016-0)Marketed from Feb 2, 2022
71335-1016-1	7133510160171335101601	30 TABLET in 1 BOTTLE (71335-1016-1)Marketed from Mar 11, 2019
71335-1016-2	7133510160271335101602	60 TABLET in 1 BOTTLE (71335-1016-2)Marketed from Jan 15, 2019
71335-1016-3	7133510160371335101603	90 TABLET in 1 BOTTLE (71335-1016-3)Marketed from Jan 17, 2019
71335-1016-4	7133510160471335101604	120 TABLET in 1 BOTTLE (71335-1016-4)Marketed from Mar 5, 2019
71335-1016-5	7133510160571335101605	20 TABLET in 1 BOTTLE (71335-1016-5)Marketed from Feb 19, 2019
71335-1016-6	7133510160671335101606	45 TABLET in 1 BOTTLE (71335-1016-6)Marketed from Jun 21, 2019
71335-1016-7	7133510160771335101607	140 TABLET in 1 BOTTLE (71335-1016-7)Marketed from Feb 2, 2022
71335-1016-8	7133510160871335101608	84 TABLET in 1 BOTTLE (71335-1016-8)Marketed from Feb 2, 2022
71335-1016-9	7133510160971335101609	28 TABLET in 1 BOTTLE (71335-1016-9)Marketed from Feb 2, 2022

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: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076416
Marketing start: Dec 11, 2003
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 71335-1016_f623a735-841a-4e73-ae38-e4d5d27a055fSPL ID f623a735-841a-4e73-ae38-e4d5d27a055fSPL set ID 03fa03a6-fd05-4f17-872a-3c123330935dRxCUI 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

N471335101600 followed by a unit qualifier and the quantity

Package 71335-1016-00. 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 Nov 9, 2023.

Indications (excerpt from the label)

Tizanidine Tablets, USP 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, USP should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration(2.1) ]. Tizanidine Tablets, USP 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, USP should be reserved for those daily activities and times when relief of spasticity is most important [ see Dosage and Administration (1) ].…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-1016

What is NDC 71335-1016?: 71335-1016 is the product NDC for Tizanidine, Tizanidine hydrochloride 4 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 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?: Bryant Ranch Prepack, NDC labeler code 71335. 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 076416

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

FDA NDC Directory listings under ANDA 076416
Product	Strength	Form · route	Labeler	Product NDC
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Northwind Health Company, LLC	51655-740
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	57664-502
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	57664-503
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Proficient Rx LP	63187-673
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Bryant Ranch Prepack	63629-2370
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Bryant Ranch Prepack	63629-2371
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Bryant Ranch Prepack	63629-7037
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Bryant Ranch Prepack	63629-8533
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	REMEDYREPACK INC.	70518-3181
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Proficient Rx LP	71205-311
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Bryant Ranch Prepack	71335-1799
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Bryant Ranch Prepack	71335-3016
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-864
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Bryant Ranch Prepack	72162-1641
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Bryant Ranch Prepack	72162-1642
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	Direct_rx	72189-602
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-325
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-326
Tizanidine	Tizanidine hydrochloride 4 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-327
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Asclemed USA, Inc.	76420-338

Showing 20 of 24.