Prescription drug · ANDA

Tizanidine NDC 63629-1673

Tizanidine hydrochloride 4 mg/1 · Tablet · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)63629-1673Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-1673Add 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
63629-1673-06362916730063629167300112 TABLET in 1 BOTTLE (63629-1673-0)Marketed from Jul 3, 2002
63629-1673-1636291673016362916730130 TABLET in 1 BOTTLE (63629-1673-1)Marketed from Jul 3, 2002
63629-1673-2636291673026362916730260 TABLET in 1 BOTTLE (63629-1673-2)Marketed from Jul 3, 2002
63629-1673-3636291673036362916730390 TABLET in 1 BOTTLE (63629-1673-3)Marketed from Jul 3, 2002
63629-1673-46362916730463629167304120 TABLET in 1 BOTTLE (63629-1673-4)Marketed from Jul 3, 2002
63629-1673-5636291673056362916730520 TABLET in 1 BOTTLE (63629-1673-5)Marketed from Jul 3, 2002
63629-1673-6636291673066362916730645 TABLET in 1 BOTTLE (63629-1673-6)Marketed from Jul 3, 2002
63629-1673-76362916730763629167307140 TABLET in 1 BOTTLE (63629-1673-7)Marketed from Jul 3, 2002
63629-1673-8636291673086362916730884 TABLET in 1 BOTTLE (63629-1673-8)Marketed from Jul 3, 2002
63629-1673-9636291673096362916730928 TABLET in 1 BOTTLE (63629-1673-9)Marketed from Jul 3, 2002

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
Bryant Ranch PrepackNDC labeler code 63629
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 63629-1673_b87823c8-5dc9-4558-b145-b4b4ff8a7d25SPL ID b87823c8-5dc9-4558-b145-b4b4ff8a7d25SPL set ID b254a0f4-efb1-4874-ae45-1dc5fe316964RxCUI 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

N463629167300 followed by a unit qualifier and the quantity

Package 63629-1673-00. 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 tablet is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine tablets should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration ( 2.1 ) ]. Tizanidine tablet is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine tablet should be reserved for those daily activities and times when relief of spasticity is most important. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-1673

What is NDC 63629-1673?
63629-1673 is the product NDC for Tizanidine, Tizanidine hydrochloride 4 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 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?
Bryant Ranch Prepack, NDC labeler code 63629. 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 4 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-455
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 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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