Tizanidine NDC 67877-614

NDC codes

FDA NDC Directory

Product NDC (as listed)67877-614Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67877-0614Add 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
67877-614-05	67877061405	500 TABLET in 1 BOTTLE (67877-614-05)Marketed from Jan 27, 2019
67877-614-15	67877061415	150 TABLET in 1 BOTTLE (67877-614-15)Marketed from Jan 27, 2019

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: Ascend Laboratories, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211798
Marketing start: Jan 27, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 67877-614_e9f19258-b62c-471d-82c4-1e2bdc030833SPL ID e9f19258-b62c-471d-82c4-1e2bdc030833SPL set ID 72f25135-1333-4e52-83f5-7df7d90e68bbRxCUI 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

N467877061405 followed by a unit qualifier and the quantity

Package 67877-0614-05. 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 13, 2023.

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211798

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

FDA NDC Directory listings under ANDA 211798
Product	Strength	Form · route	Labeler	Product NDC
Tizanidine	Tizanidine hydrochloride 2 mg/1	TabletOral	Ascend Laboratories, LLC	67877-613