NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8798Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8798Add 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
68788-8798-16878887980168788879801100 CAPSULE in 1 BOTTLE (68788-8798-1)Marketed from Jan 1, 2025
68788-8798-2687888798026878887980220 CAPSULE in 1 BOTTLE (68788-8798-2)Marketed from Jan 1, 2025
68788-8798-3687888798036878887980330 CAPSULE in 1 BOTTLE (68788-8798-3)Marketed from Jan 1, 2025
68788-8798-6687888798066878887980660 CAPSULE in 1 BOTTLE (68788-8798-6)Marketed from Jan 1, 2025
68788-8798-86878887980868788879808120 CAPSULE in 1 BOTTLE (68788-8798-8)Marketed from Jan 1, 2025
68788-8798-9687888798096878887980990 CAPSULE in 1 BOTTLE (68788-8798-9)Marketed from Jan 1, 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)
Tizanidne hydrochloride
Generic name (nonproprietary)
tizanidne 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 212196
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha2-Agonists (Mechanism)
Identifiers
Product ID 68788-8798_ff9d2f6a-8654-4dbe-ab07-4f9cacda54aeSPL ID ff9d2f6a-8654-4dbe-ab07-4f9cacda54aeSPL set ID 3f569c5a-ec9d-4356-ac04-c17714ff68d1RxCUI 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

N468788879801 followed by a unit qualifier and the quantity

Package 68788-8798-01. 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 capsules are indicated for the treatment of spasticity in adults. Tizanidine capsules are 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 68788-8798

What is NDC 68788-8798?
68788-8798 is the product NDC for Tizanidne 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?
Tizanidne 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 Tizanidne hydrochloride?
14 other product NDCs are listed under this name. See all Tizanidne 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 Tizanidne hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Tizanidne hydrochlorideTizanidine hydrochloride 2 mg/1CapsuleOralBryant Ranch Prepack63629-887163629-8871-01
Tizanidne hydrochlorideTizanidine hydrochloride 4 mg/1CapsuleOralBryant Ranch Prepack63629-887263629-8872-01
Tizanidne hydrochlorideTizanidine hydrochloride 6 mg/1CapsuleOralBryant Ranch Prepack63629-887363629-8873-01
Tizanidne hydrochlorideTizanidine hydrochloride 2 mg/1CapsuleOralAscend Laboratories, LLC67877-61067877-0610-0567877-0610-1567877-0610-33
Tizanidne hydrochlorideTizanidine hydrochloride 4 mg/1CapsuleOralAscend Laboratories, LLC67877-61167877-0611-0567877-0611-1567877-0611-33
Tizanidne hydrochlorideTizanidine hydrochloride 6 mg/1CapsuleOralAscend Laboratories, LLC67877-61267877-0612-0567877-0612-1567877-0612-33
Tizanidne hydrochlorideTizanidine hydrochloride 6 mg/1CapsuleOralBryant Ranch Prepack71335-207771335-2077-0171335-2077-0271335-2077-03+2 more
Tizanidne hydrochlorideTizanidine hydrochloride 2 mg/1CapsuleOralBryant Ranch Prepack71335-220871335-2208-01
Tizanidne hydrochlorideTizanidine hydrochloride 4 mg/1CapsuleOralBryant Ranch Prepack71335-220971335-2209-01
Tizanidne hydrochlorideTizanidine hydrochloride 6 mg/1CapsuleOralBryant Ranch Prepack71335-221071335-2210-01

All 15 Tizanidne hydrochloride NDCs

Other NDCs under ANDA 212196

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

FDA NDC Directory listings under ANDA 212196
ProductStrengthForm · routeLabelerProduct NDC
Tizanidine HCLTizanidine hydrochloride 4 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0144
Tizanidine HydrochlorideTizanidine hydrochloride 2 mg/1CapsuleOralAsclemed USA, Inc.76420-900
Tizanidine HydrochlorideTizanidine hydrochloride 4 mg/1CapsuleOralAsclemed USA, Inc.76420-901
Tizanidine HydrochlorideTizanidine hydrochloride 6 mg/1CapsuleOralAsclemed USA, Inc.76420-902
Tizanidne hydrochlorideTizanidine hydrochloride 2 mg/1CapsuleOralBryant Ranch Prepack63629-8871
Tizanidne hydrochlorideTizanidine hydrochloride 4 mg/1CapsuleOralBryant Ranch Prepack63629-8872
Tizanidne hydrochlorideTizanidine hydrochloride 6 mg/1CapsuleOralBryant Ranch Prepack63629-8873
Tizanidne hydrochlorideTizanidine hydrochloride 2 mg/1CapsuleOralAscend Laboratories, LLC67877-610
Tizanidne hydrochlorideTizanidine hydrochloride 4 mg/1CapsuleOralAscend Laboratories, LLC67877-611
Tizanidne hydrochlorideTizanidine hydrochloride 6 mg/1CapsuleOralAscend Laboratories, LLC67877-612
Tizanidne hydrochlorideTizanidine hydrochloride 6 mg/1CapsuleOralBryant Ranch Prepack71335-2077
Tizanidne hydrochlorideTizanidine hydrochloride 2 mg/1CapsuleOralBryant Ranch Prepack71335-2208
Tizanidne hydrochlorideTizanidine hydrochloride 4 mg/1CapsuleOralBryant Ranch Prepack71335-2209
Tizanidne hydrochlorideTizanidine hydrochloride 6 mg/1CapsuleOralBryant Ranch Prepack71335-2210
Tizanidne hydrochlorideTizanidine hydrochloride 2 mg/1CapsuleOralBryant Ranch Prepack72162-1860
Tizanidne hydrochlorideTizanidine hydrochloride 4 mg/1CapsuleOralBryant Ranch Prepack72162-1861
Tizanidne hydrochlorideTizanidine hydrochloride 6 mg/1CapsuleOralBryant Ranch Prepack72162-1862
Tizanidne hydrochlorideTizanidine hydrochloride 6 mg/1CapsuleOralAsclemed USA, Inc.76420-231

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