What is NDC 0591-2788?

0591-2788 is the product NDC for tizanidine hydrochloride, Tizanidine hydrochloride 2 mg/1 capsule, gelatin coated, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Actavis Pharma, Inc., NDC labeler code 0591. 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 0591-2788

NDC codes

FDA NDC Directory

Product NDC (as listed)0591-2788Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00591-2788Add 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
0591-2788-86	0059127888600591278886	150 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0591-2788-86)Marketed from Feb 6, 2012

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 2 mg/1
Dosage form: Capsule, Gelatin coated
Route: Oral
Labeler: Actavis Pharma, Inc.NDC labeler code 0591
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 021447
Marketing start: Feb 6, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 0591-2788_5c8f8c47-4f62-4954-8135-957c967dd7cbSPL ID 5c8f8c47-4f62-4954-8135-957c967dd7cbSPL set ID cb8b01b3-bcec-4762-9d67-0db018ef6b22RxCUI 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

N400591278886 followed by a unit qualifier and the quantity

Package 00591-2788-86. 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 Mar 10, 2023.

Indications (excerpt from the label)

Tizanidine hydrochloride capsules are indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration ( 2.1 )] . Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride 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 0591-2788

What is NDC 0591-2788?: 0591-2788 is the product NDC for tizanidine hydrochloride, Tizanidine hydrochloride 2 mg/1 capsule, gelatin coated, listed with the FDA by Actavis Pharma, Inc.. 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?: Actavis Pharma, Inc., NDC labeler code 0591. 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 NDA 021447

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

FDA NDC Directory listings under NDA 021447
Product	Strength	Form · route	Labeler	Product NDC
tizanidine hydrochloride	Tizanidine hydrochloride 4 mg/1	Capsule, Gelatin coatedOral	Actavis Pharma, Inc.	0591-2789
tizanidine hydrochloride	Tizanidine hydrochloride 6 mg/1	Capsule, Gelatin coatedOral	Actavis Pharma, Inc.	0591-2790
Zanaflextizanidine hydrochloride	Tizanidine hydrochloride 2 mg/1	CapsuleOral	Covis Pharma US, Inc	70515-602
Zanaflextizanidine hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Covis Pharma US, Inc	70515-604
Zanaflextizanidine hydrochloride	Tizanidine hydrochloride 6 mg/1	CapsuleOral	Covis Pharma US, Inc	70515-606
Zanaflextizanidine hydrochloride	Tizanidine hydrochloride 2 mg/1	CapsuleOral	Legacy Pharma USA, Inc.	83107-001
Zanaflextizanidine hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Legacy Pharma USA, Inc.	83107-002
Zanaflextizanidine hydrochloride	Tizanidine hydrochloride 6 mg/1	CapsuleOral	Legacy Pharma USA, Inc.	83107-003