NDC codes

FDA NDC Directory
Product NDC (as listed)61919-196Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61919-0196Add 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
61919-196-20619190196206191901962020 TABLET in 1 BOTTLE (61919-196-20)Marketed from Jan 1, 2014
61919-196-30619190196306191901963030 TABLET in 1 BOTTLE (61919-196-30)Marketed from Jan 1, 2015
61919-196-40619190196406191901964040 TABLET in 1 BOTTLE (61919-196-40)Marketed from Jan 1, 2014
61919-196-60619190196606191901966060 TABLET in 1 BOTTLE (61919-196-60)Marketed from Jan 1, 2015
61919-196-72619190196726191901967272 TABLET in 1 BOTTLE (61919-196-72)Marketed from Jan 1, 2015
61919-196-90619190196906191901969090 TABLET in 1 BOTTLE (61919-196-90)Marketed from Jan 1, 2015

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 Hydrochloride
Generic name (nonproprietary)
tizanidine hydrochloride
Active ingredients
Tizanidine hydrochloride — 4 mg/1
Dosage form
Tablet
Route
Oral
Labeler
TIZANIDINE HYDROCHLORIDENDC labeler code 61919
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091283
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha2-Agonists (Mechanism)
Identifiers
Product ID 61919-196_4c484458-33e2-e0cc-e063-6294a90a9e28SPL ID 4c484458-33e2-e0cc-e063-6294a90a9e28SPL set ID 047c67cd-7a63-49c9-b100-71651d3537baRxCUI 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

N461919019620 followed by a unit qualifier and the quantity

Package 61919-0196-20. 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)

INDICATIONS & USAGE SECTION Tizanidine tablet is a short-acting drug for the management of spasticity. Because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important (see DOSAGE AND ADMINISTRATION).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61919-196

What is NDC 61919-196?
61919-196 is the product NDC for Tizanidine Hydrochloride, Tizanidine hydrochloride 4 mg/1 tablet, listed with the FDA by TIZANIDINE HYDROCHLORIDE. 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?
TIZANIDINE HYDROCHLORIDE, NDC labeler code 61919. 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 4 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-877668788-8776-0168788-8776-0268788-8776-03+3 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

All 55 Tizanidine Hydrochloride NDCs

Other NDCs under ANDA 091283

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

FDA NDC Directory listings under ANDA 091283
ProductStrengthForm · routeLabelerProduct NDC
TizandineTizanidine hydrochloride 2 mg/1TabletOralDirect_Rx61919-811
TizanidineTizanidine hydrochloride 2 mg/1TabletOralUnichem Pharmaceuticals (USA), Inc.29300-168
TizanidineTizanidine hydrochloride 4 mg/1TabletOralUnichem Pharmaceuticals (USA), Inc.29300-169
TizanidineTizanidine hydrochloride 2 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-868
TizanidineTizanidine hydrochloride 2 mg/1TabletOralA-S Medication Solutions50090-2078
TizanidineTizanidine hydrochloride 4 mg/1TabletOralA-S Medication Solutions50090-5767
TizanidineTizanidine hydrochloride 4 mg/1TabletOralA-S Medication Solutions50090-7889
TizanidineTizanidine hydrochloride 4 mg/1TabletOralProficient Rx LP63187-493
TizanidineTizanidine hydrochloride 2 mg/1TabletOralProficient Rx LP63187-910
TizanidineTizanidine hydrochloride 2 mg/1TabletOralRedpharm Drug67296-2209
TizanidineTizanidine hydrochloride 4 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4463
TizanidineTizanidine hydrochloride 4 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8802
TizanidineTizanidine hydrochloride 4 mg/1TabletOralREMEDYREPACK INC.70518-1598
TizanidineTizanidine hydrochloride 2 mg/1TabletOralBryant Ranch Prepack71335-0424
TizanidineTizanidine hydrochloride 4 mg/1TabletOralBryant Ranch Prepack71335-0914
TizanidineTizanidine hydrochloride 4 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-228
TizanidineTizanidine hydrochloride 2 mg/1TabletOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0187
Tizanidine HCLTizanidine hydrochloride 4 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0024

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