NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8776Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8776Add 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
68788-8776-16878887760168788877601100 CAPSULE in 1 BOTTLE (68788-8776-1)Marketed from Dec 9, 2024
68788-8776-2687888776026878887760220 CAPSULE in 1 BOTTLE (68788-8776-2)Marketed from Dec 9, 2024
68788-8776-3687888776036878887760330 CAPSULE in 1 BOTTLE (68788-8776-3)Marketed from Dec 9, 2024
68788-8776-6687888776066878887760660 CAPSULE in 1 BOTTLE (68788-8776-6)Marketed from Dec 9, 2024
68788-8776-86878887760868788877608120 CAPSULE in 1 BOTTLE (68788-8776-8)Marketed from Dec 9, 2024
68788-8776-9687888776096878887760990 CAPSULE in 1 BOTTLE (68788-8776-9)Marketed from Dec 9, 2024

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 hydrochloride
Generic name (nonproprietary)
tizanidine hydrochloride
Active ingredients
Tizanidine hydrochloride — 4 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213798
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha2-Agonists (Mechanism)
Identifiers
Product ID 68788-8776_62f55001-6aa3-4baa-b6d2-564c09dab4edSPL ID 62f55001-6aa3-4baa-b6d2-564c09dab4edSPL set ID ebccdb33-2b3c-4071-9765-8d95bcbc9b5fRxCUI 485485UNII 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

N468788877601 followed by a unit qualifier and the quantity

Package 68788-8776-01. 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 hydrochloride is indicated for the treatment of spasticity in adults. Tizanidine hydrochloride is 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 68788-8776

What is NDC 68788-8776?
68788-8776 is the product NDC for tizanidine hydrochloride, Tizanidine hydrochloride 4 mg/1 capsule, 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 hydrochloride.
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 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Tizanidine HydrochlorideTizanidine hydrochloride 8 mg/1CapsuleOralTrifluent Pharma, LLC73352-08973352-0089-60
tizanidine hydrochlorideTizanidine hydrochloride 8 mg/1CapsuleOralAdvagen Pharma Limited72888-16172888-0161-15
tizanidine hydrochlorideTizanidine hydrochloride 4 mg/1CapsuleOralAdvanced Rx of Tennessee, LLC80425-047480425-0474-0180425-0474-0280425-0474-03+1 more
Tizanidine HydrochlorideTizanidine hydrochloride 6 mg/1CapsuleOralAdvanced Rx of Tennessee, LLC80425-044880425-0448-0180425-0448-0280425-0448-03
Tizanidine HydrochlorideTizanidine hydrochloride 4 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-874768788-8747-0168788-8747-0268788-8747-03+3 more
Tizanidine HydrochlorideTizanidine hydrochloride 6 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-847868788-8478-0168788-8478-0368788-8478-06+1 more
tizanidine hydrochlorideTizanidine hydrochloride 4 mg/1CapsuleOralBryant Ranch Prepack71335-255971335-2559-0171335-2559-0271335-2559-03+1 more
tizanidine hydrochlorideTizanidine hydrochloride 6 mg/1CapsuleOralBryant Ranch Prepack71335-287271335-2872-0171335-2872-0271335-2872-03+2 more
tizanidine hydrochlorideTizanidine hydrochloride 6 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.72789-50572789-0505-77
tizanidine hydrochlorideTizanidine hydrochloride 2 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.72789-50672789-0506-77

All 55 tizanidine hydrochloride NDCs

Other NDCs under ANDA 213798

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

FDA NDC Directory listings under ANDA 213798
ProductStrengthForm · routeLabelerProduct NDC
TizanidineTizanidine hydrochloride 6 mg/1CapsuleOralDirect_Rx72189-678
tizanidine hydrochlorideTizanidine hydrochloride 4 mg/1CapsuleOralBryant Ranch Prepack71335-2559
tizanidine hydrochlorideTizanidine hydrochloride 6 mg/1CapsuleOralBryant Ranch Prepack71335-2872
tizanidine hydrochlorideTizanidine hydrochloride 6 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.72789-505
tizanidine hydrochlorideTizanidine hydrochloride 2 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.72789-506
tizanidine hydrochlorideTizanidine hydrochloride 4 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.72789-507
tizanidine hydrochlorideTizanidine hydrochloride 2 mg/1CapsuleOralAdvagen Pharma Limited72888-001
tizanidine hydrochlorideTizanidine hydrochloride 4 mg/1CapsuleOralAdvagen Pharma Limited72888-002
tizanidine hydrochlorideTizanidine hydrochloride 6 mg/1CapsuleOralAdvagen Pharma Limited72888-003
tizanidine hydrochlorideTizanidine hydrochloride 8 mg/1CapsuleOralAdvagen Pharma Limited72888-161
Tizanidine HydrochlorideTizanidine hydrochloride 8 mg/1CapsuleOralTrifluent Pharma, LLC73352-089
tizanidine hydrochlorideTizanidine hydrochloride 4 mg/1CapsuleOralAdvanced Rx of Tennessee, LLC80425-0474
Zanaflextizanidine hydrochlorideTizanidine hydrochloride 8 mg/1CapsuleOralTrifluent Pharma, LLC73352-090

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