NDC codes

FDA NDC Directory
Product NDC (as listed)43063-455Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43063-0455Add 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
43063-455-15430630455154306304551515 TABLET in 1 BOTTLE, PLASTIC (43063-455-15)Marketed from Nov 22, 2016
43063-455-20430630455204306304552020 TABLET in 1 BOTTLE, PLASTIC (43063-455-20)Marketed from Nov 22, 2016
43063-455-30430630455304306304553030 TABLET in 1 BOTTLE, PLASTIC (43063-455-30)Marketed from Nov 22, 2016
43063-455-40430630455404306304554040 TABLET in 1 BOTTLE, PLASTIC (43063-455-40)Marketed from Jun 1, 2020
43063-455-60430630455604306304556060 TABLET in 1 BOTTLE, PLASTIC (43063-455-60)Marketed from Jun 1, 2020
43063-455-90430630455904306304559090 TABLET in 1 BOTTLE, PLASTIC (43063-455-90)Marketed from Jun 1, 2020

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
PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076286
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha2-Agonists (Mechanism)
Identifiers
Product ID 43063-455_47d2acba-fb93-f1a3-e063-6394a90aa13fSPL ID 47d2acba-fb93-f1a3-e063-6394a90aa13fSPL set ID ac897a5a-677b-4a6e-abb1-b810470200fcRxCUI 313413UNII B53E3NMY5CUPC 0343063455906
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

N443063045515 followed by a unit qualifier and the quantity

Package 43063-0455-15. 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 tablets are indicated for the treatment of spasticity in adults. Tizanidine tablet 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 43063-455

What is NDC 43063-455?
43063-455 is the product NDC for Tizanidine, Tizanidine hydrochloride 4 mg/1 tablet, listed with the FDA by PD-Rx 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?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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 076286

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

FDA NDC Directory listings under ANDA 076286
ProductStrengthForm · routeLabelerProduct NDC
TizanidineTizanidine hydrochloride 2 mg/1TabletOralNorthStar Rx LLC16714-171
TizanidineTizanidine hydrochloride 4 mg/1TabletOralNorthStar Rx LLC16714-172
TizanidineTizanidine hydrochloride 2 mg/1TabletOralQuality Care Products, LLC35356-662
TizanidineTizanidine hydrochloride 2 mg/1TabletOralA-S Medication Solutions50090-0811
TizanidineTizanidine hydrochloride 4 mg/1TabletOralA-S Medication Solutions50090-0840
TizanidineTizanidine hydrochloride 4 mg/1TabletOralA-S Medication Solutions50090-6756
TizanidineTizanidine hydrochloride 4 mg/1TabletOralA-S Medication Solutions50090-6757
TizanidineTizanidine hydrochloride 2 mg/1TabletOralAvPAK50268-759
TizanidineTizanidine hydrochloride 4 mg/1TabletOralAvPAK50268-760
TizanidineTizanidine hydrochloride 4 mg/1TabletOralNorthwind Health Company, LLC51655-603
TizanidineTizanidine hydrochloride 2 mg/1TabletOralDr. Reddy's Laboratories Limited55111-179
TizanidineTizanidine hydrochloride 4 mg/1TabletOralDr. Reddy's Laboratories Limited55111-180
TizanidineTizanidine hydrochloride 4 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-505
TizanidineTizanidine hydrochloride 2 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-694
TizanidineTizanidine hydrochloride 4 mg/1TabletOralProficient Rx LP63187-009
TizanidineTizanidine hydrochloride 4 mg/1TabletOralBryant Ranch Prepack63629-1673
TizanidineTizanidine hydrochloride 2 mg/1TabletOralBryant Ranch Prepack63629-3209
TizanidineTizanidine hydrochloride 4 mg/1TabletOralRedpharm Drug67296-2263
TizanidineTizanidine hydrochloride 2 mg/1TabletOralRedpharm Drug67296-2316
TizanidineTizanidine hydrochloride 2 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3440

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