What is NDC 59651-316?

59651-316 is the product NDC for Tizanidine Hydrochloride, Tizanidine hydrochloride 6 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 59651. 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 59651-316

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-316Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0316Add 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
59651-316-77	5965103167759651031677	150 CAPSULE in 1 BOTTLE (59651-316-77)Marketed from Mar 24, 2020

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 Hydrochloride
Generic name (nonproprietary): tizanidine hydrochloride
Active ingredients: Tizanidine hydrochloride — 6 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Aurobindo Pharma LimitedNDC labeler code 59651
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213544
Marketing start: Mar 24, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 59651-316_c5462b0a-179b-449f-87e9-1ccfa18367b3SPL ID c5462b0a-179b-449f-87e9-1ccfa18367b3SPL set ID 19cf46b5-d8dc-44cb-83d6-bacea0870dbeRxCUI 485484, 485485, 485486UNII 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

N459651031677 followed by a unit qualifier and the quantity

Package 59651-0316-77. 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 17, 2025.

Indications (excerpt from the label)

Tizanidine capsules are indicated for the treatment of spasticity in adults. Tizanidine capsules are a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59651-316

What is NDC 59651-316?: 59651-316 is the product NDC for Tizanidine Hydrochloride, Tizanidine hydrochloride 6 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, 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?: Aurobindo Pharma Limited, NDC labeler code 59651. 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 6 mg/1	CapsuleOral	Advanced Rx of Tennessee, LLC	80425-0448	80425-0448-0180425-0448-0280425-0448-03
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

All 55 Tizanidine Hydrochloride NDCs

Other NDCs under ANDA 213544

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

FDA NDC Directory listings under ANDA 213544
Product	Strength	Form · route	Labeler	Product NDC
Tizanidine Hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-315