What is NDC 76420-231?

76420-231 is the product NDC for Tizanidne hydrochloride, Tizanidine hydrochloride 6 mg/1 capsule, listed with the FDA by Asclemed USA, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

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 Tizanidne hydrochloride?

14 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tizanidne hydrochloride NDC 76420-231

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-231Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0231Add 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 NDC	11-digit (billing)	Package
76420-231-30	7642002313076420023130	30 CAPSULE in 1 BOTTLE (76420-231-30)Marketed from Jul 7, 2022
76420-231-60	7642002316076420023160	60 CAPSULE in 1 BOTTLE (76420-231-60)Marketed from Jul 7, 2022
76420-231-90	7642002319076420023190	90 CAPSULE in 1 BOTTLE (76420-231-90)Marketed from Jul 7, 2022

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): Tizanidne hydrochloride
Generic name (nonproprietary): tizanidne hydrochloride
Active ingredients: Tizanidine hydrochloride — 6 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Asclemed USA, Inc.NDC labeler code 76420
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212196
Marketing start: Mar 29, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)
Identifiers: Product ID 76420-231_e347f58a-9fc4-7e64-e053-2a95a90a528bSPL ID e347f58a-9fc4-7e64-e053-2a95a90a528bSPL set ID 1ad6eaf6-bd32-4d05-bdd0-a6246e2afb9cRxCUI 485484UNII 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

N476420023130 followed by a unit qualifier and the quantity

Package 76420-0231-30. 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 Jul 7, 2022.

Indications (excerpt from the label)

Tizanidine hydrochloride is indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration ( 2.1 )]. Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules 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 76420-231

What is NDC 76420-231?: 76420-231 is the product NDC for Tizanidne hydrochloride, Tizanidine hydrochloride 6 mg/1 capsule, listed with the FDA by Asclemed USA, Inc.. It has 3 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?: 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 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tizanidne hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-8798	68788-8798-0168788-8798-0268788-8798-03+3 more
Tizanidne hydrochloride	Tizanidine hydrochloride 2 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8871	63629-8871-01
Tizanidne hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8872	63629-8872-01
Tizanidne hydrochloride	Tizanidine hydrochloride 6 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8873	63629-8873-01
Tizanidne hydrochloride	Tizanidine hydrochloride 2 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-610	67877-0610-0567877-0610-1567877-0610-33
Tizanidne hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-611	67877-0611-0567877-0611-1567877-0611-33
Tizanidne hydrochloride	Tizanidine hydrochloride 6 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-612	67877-0612-0567877-0612-1567877-0612-33
Tizanidne hydrochloride	Tizanidine hydrochloride 6 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2077	71335-2077-0171335-2077-0271335-2077-03+2 more
Tizanidne hydrochloride	Tizanidine hydrochloride 2 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2208	71335-2208-01
Tizanidne hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2209	71335-2209-01

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
Product	Strength	Form · route	Labeler	Product NDC
Tizanidine HCL	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0144
Tizanidine Hydrochloride	Tizanidine hydrochloride 2 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-900
Tizanidine Hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-901
Tizanidine Hydrochloride	Tizanidine hydrochloride 6 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-902
Tizanidne hydrochloride	Tizanidine hydrochloride 2 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8871
Tizanidne hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8872
Tizanidne hydrochloride	Tizanidine hydrochloride 6 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8873
Tizanidne hydrochloride	Tizanidine hydrochloride 2 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-610
Tizanidne hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-611
Tizanidne hydrochloride	Tizanidine hydrochloride 6 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-612
Tizanidne hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-8798
Tizanidne hydrochloride	Tizanidine hydrochloride 6 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2077
Tizanidne hydrochloride	Tizanidine hydrochloride 2 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2208
Tizanidne hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2209
Tizanidne hydrochloride	Tizanidine hydrochloride 6 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2210
Tizanidne hydrochloride	Tizanidine hydrochloride 2 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-1860
Tizanidne hydrochloride	Tizanidine hydrochloride 4 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-1861
Tizanidne hydrochloride	Tizanidine hydrochloride 6 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-1862