Prescription drug · ANDA
Tizanidine NDC 72189-526
Tizanidine hydrochloride 6 mg/1 · Capsule · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-526-30 | 7218905263072189052630 | 30 CAPSULE in 1 BOTTLE (72189-526-30)Marketed from Dec 6, 2023 | |
| 72189-526-60 | 7218905266072189052660 | 60 CAPSULE in 1 BOTTLE (72189-526-60)Marketed from Dec 6, 2023 |
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 — 6 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Direct_RxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210267
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 72189-526_3cbc5365-9206-61c0-e063-6294a90aa3b7SPL ID 3cbc5365-9206-61c0-e063-6294a90aa3b7SPL set ID 0bdc188d-b895-acbc-e063-6294a90acd68RxCUI 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
N472189052630followed by a unit qualifier and the quantityPackage 72189-0526-30. 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 .
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 capsules should be reserved for those daily activities and times when relief of spasticity is most important [see DOSAGE AND ADMINISTRATION (2.1)].
Excerpt only. Read the full label for complete information.
About NDC 72189-526
- What is NDC 72189-526?
- 72189-526 is the product NDC for Tizanidine, Tizanidine hydrochloride 6 mg/1 capsule, listed with the FDA by Direct_Rx. It has 2 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?
- Direct_Rx, NDC labeler code 72189. 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?
- 111 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.
Related NDCs: other Tizanidine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Aurobindo Pharma Limited | 84386-023 | 84386-0023-7784386-0023-99 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Aurobindo Pharma Limited | 84386-024 | 84386-0024-7784386-0024-99 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4159 | 68788-4159-0168788-4159-0268788-4159-03+3 more |
| Tizanidine | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Direct_Rx | 72189-678 | 72189-0678-30 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Medcore LLC | 82461-720 | 82461-0720-60 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Medcore LLC | 82461-721 | 82461-0721-60 |
| tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0500 | 80425-0500-0180425-0500-0280425-0500-03 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8802 | 68788-8802-0168788-8802-0268788-8802-03+3 more |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Direct_rx | 72189-602 | 72189-0602-3072189-0602-6072189-0602-90 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Direct_rx | 72189-599 | 72189-0599-3072189-0599-6072189-0599-82+1 more |
Other NDCs under ANDA 210267
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tizanidine HCL | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0090 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 2 mg/1 | CapsuleOral | Ingenus Pharmaceuticals, LLC | 50742-224 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Ingenus Pharmaceuticals, LLC | 50742-225 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Ingenus Pharmaceuticals, LLC | 50742-226 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-892 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8478 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8747 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-9743 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0448 |