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 NDC11-digit (billing)PackageCopy
67877-614-056787706140567877061405500 TABLET in 1 BOTTLE (67877-614-05)Marketed from Jan 27, 2019
67877-614-156787706141567877061415150 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, LLCNDC labeler code 67877
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211798
Marketing start
Listing expires
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 .

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)

About NDC 67877-614

What is NDC 67877-614?
67877-614 is the product NDC for Tizanidine, Tizanidine hydrochloride 4 mg/1 tablet, listed with the FDA by Ascend Laboratories, LLC. It has 2 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?
Ascend Laboratories, LLC, NDC labeler code 67877. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TizanidineTizanidine hydrochloride 2 mg/1TabletOralAurobindo Pharma Limited84386-02384386-0023-7784386-0023-99
TizanidineTizanidine hydrochloride 4 mg/1TabletOralAurobindo Pharma Limited84386-02484386-0024-7784386-0024-99
tizanidineTizanidine hydrochloride 4 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-415968788-4159-0168788-4159-0268788-4159-03+3 more
TizanidineTizanidine hydrochloride 6 mg/1CapsuleOralDirect_Rx72189-67872189-0678-30
TizanidineTizanidine hydrochloride 2 mg/1TabletOralMedcore LLC82461-72082461-0720-60
TizanidineTizanidine hydrochloride 4 mg/1TabletOralMedcore LLC82461-72182461-0721-60
tizanidineTizanidine hydrochloride 2 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-050080425-0500-0180425-0500-0280425-0500-03
TizanidineTizanidine hydrochloride 4 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-880268788-8802-0168788-8802-0268788-8802-03+3 more
TizanidineTizanidine hydrochloride 4 mg/1TabletOralDirect_rx72189-60272189-0602-3072189-0602-6072189-0602-90
TizanidineTizanidine hydrochloride 2 mg/1TabletOralDirect_rx72189-59972189-0599-3072189-0599-6072189-0599-82+1 more

All 111 Tizanidine NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
TizanidineTizanidine hydrochloride 2 mg/1TabletOralAscend Laboratories, LLC67877-613

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