NDC codes

FDA NDC Directory
Product NDC (as listed)76420-885Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76420-0885Add 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
76420-885-0076420088500764200885001000 TABLET in 1 BOTTLE (76420-885-00)Marketed from Dec 27, 2024
76420-885-017642008850176420088501100 TABLET in 1 BOTTLE (76420-885-01)Marketed from Dec 27, 2024
76420-885-11764200885117642008851110 TABLET in 1 BLISTER PACK (76420-885-11)Marketed from Dec 27, 2024
76420-885-15764200885157642008851515 TABLET in 1 BOTTLE (76420-885-15)Marketed from Dec 27, 2024
76420-885-217642008852176420088521150 TABLET in 1 BOTTLE (76420-885-21)Marketed from Dec 27, 2024
76420-885-30764200885307642008853030 TABLET in 1 BOTTLE (76420-885-30)Marketed from Dec 27, 2024
76420-885-60764200885607642008856060 TABLET in 1 BOTTLE (76420-885-60)Marketed from Dec 27, 2024
76420-885-88764200885887642008858810 TABLET in 1 BOTTLE (76420-885-88)Marketed from Dec 27, 2024
76420-885-90764200885907642008859090 TABLET in 1 BOTTLE (76420-885-90)Marketed from Dec 27, 2024
76420-885-99764200885997642008859910 BLISTER PACK in 1 CARTON (76420-885-99) / 10 TABLET in 1 BLISTER PACKMarketed from Dec 27, 2024

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 — 2 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Asclemed USA, Inc.NDC labeler code 76420
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208187
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha2-Agonists (Mechanism)
Identifiers
Product ID 76420-885_2a395a10-4c73-4213-e063-6394a90abb25SPL ID 2a395a10-4c73-4213-e063-6394a90abb25SPL set ID a9ba9023-0c3f-4c9b-ba8e-d39d23bf35d6RxCUI 313412, 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

N476420088500 followed by a unit qualifier and the quantity

Package 76420-0885-00. 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 tablets are a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. ( 1 ) Tizanidine tablets are 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 76420-885

What is NDC 76420-885?
76420-885 is the product NDC for tizanidine, Tizanidine hydrochloride 2 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. 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?
Asclemed USA, Inc., NDC labeler code 76420. 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 208187

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

FDA NDC Directory listings under ANDA 208187
ProductStrengthForm · routeLabelerProduct NDC
tizanidineTizanidine hydrochloride 2 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8468
tizanidineTizanidine hydrochloride 4 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8469
tizanidineTizanidine hydrochloride 4 mg/1TabletOralCoupler LLC67046-1444
tizanidineTizanidine hydrochloride 4 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3719
tizanidineTizanidine hydrochloride 4 mg/1TabletOralREMEDYREPACK INC.70518-4181
tizanidineTizanidine hydrochloride 2 mg/1TabletOralZydus Lifesciences Limited70771-1335
tizanidineTizanidine hydrochloride 4 mg/1TabletOralZydus Lifesciences Limited70771-1336
tizanidineTizanidine hydrochloride 2 mg/1TabletOralViona Pharmaceuticals Inc72578-096
tizanidineTizanidine hydrochloride 4 mg/1TabletOralViona Pharmaceuticals Inc72578-097
tizanidineTizanidine hydrochloride 4 mg/1TabletOralAsclemed USA, Inc.76420-886
TizanidineTizanidine hydrochloride 2 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0436
TizanidineTizanidine hydrochloride 4 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0453
tizanidineTizanidine hydrochloride 4 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0454
tizanidineTizanidine hydrochloride 2 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0500

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