NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8802Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8802Add 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
68788-8802-16878888020168788880201100 TABLET in 1 BOTTLE (68788-8802-1)Marketed from Jan 2, 2025
68788-8802-2687888802026878888020220 TABLET in 1 BOTTLE (68788-8802-2)Marketed from Jan 2, 2025
68788-8802-3687888802036878888020330 TABLET in 1 BOTTLE (68788-8802-3)Marketed from Jan 2, 2025
68788-8802-6687888802066878888020660 TABLET in 1 BOTTLE (68788-8802-6)Marketed from Jan 2, 2025
68788-8802-86878888020868788880208120 TABLET in 1 BOTTLE (68788-8802-8)Marketed from Jan 2, 2025
68788-8802-9687888802096878888020990 TABLET in 1 BOTTLE (68788-8802-9)Marketed from Jan 2, 2025

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
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091283
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha2-Agonists (Mechanism)
Identifiers
Product ID 68788-8802_6e97c1ba-8171-4707-98ee-61afed75daacSPL ID 6e97c1ba-8171-4707-98ee-61afed75daacSPL set ID 6e97c1ba-8171-4707-98ee-61afed75daacRxCUI 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

N468788880201 followed by a unit qualifier and the quantity

Package 68788-8802-01. 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 treatment of spasticity. ( 1 ) Tizanidine is indicated for the treatment of spasticity in adults.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8802

What is NDC 68788-8802?
68788-8802 is the product NDC for Tizanidine, Tizanidine hydrochloride 4 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 6 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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/1TabletOralDirect_rx72189-60272189-0602-3072189-0602-6072189-0602-90
TizanidineTizanidine hydrochloride 2 mg/1TabletOralDirect_rx72189-59972189-0599-3072189-0599-6072189-0599-82+1 more
tizanidineTizanidine hydrochloride 2 mg/1TabletOralA-S Medication Solutions50090-771650090-7716-0050090-7716-01

All 111 Tizanidine NDCs

Other NDCs under ANDA 091283

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

FDA NDC Directory listings under ANDA 091283
ProductStrengthForm · routeLabelerProduct NDC
TizandineTizanidine hydrochloride 2 mg/1TabletOralDirect_Rx61919-811
TizanidineTizanidine hydrochloride 2 mg/1TabletOralUnichem Pharmaceuticals (USA), Inc.29300-168
TizanidineTizanidine hydrochloride 4 mg/1TabletOralUnichem Pharmaceuticals (USA), Inc.29300-169
TizanidineTizanidine hydrochloride 2 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-868
TizanidineTizanidine hydrochloride 2 mg/1TabletOralA-S Medication Solutions50090-2078
TizanidineTizanidine hydrochloride 4 mg/1TabletOralA-S Medication Solutions50090-5767
TizanidineTizanidine hydrochloride 4 mg/1TabletOralA-S Medication Solutions50090-7889
TizanidineTizanidine hydrochloride 4 mg/1TabletOralProficient Rx LP63187-493
TizanidineTizanidine hydrochloride 2 mg/1TabletOralProficient Rx LP63187-910
TizanidineTizanidine hydrochloride 2 mg/1TabletOralRedpharm Drug67296-2209
TizanidineTizanidine hydrochloride 4 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4463
TizanidineTizanidine hydrochloride 4 mg/1TabletOralREMEDYREPACK INC.70518-1598
TizanidineTizanidine hydrochloride 2 mg/1TabletOralBryant Ranch Prepack71335-0424
TizanidineTizanidine hydrochloride 4 mg/1TabletOralBryant Ranch Prepack71335-0914
TizanidineTizanidine hydrochloride 4 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-228
TizanidineTizanidine hydrochloride 2 mg/1TabletOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0187
Tizanidine HCLTizanidine hydrochloride 4 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0024
Tizanidine HydrochlorideTizanidine hydrochloride 4 mg/1TabletOralTIZANIDINE HYDROCHLORIDE61919-196

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