Prescription drug · ANDA
tizanidine NDC 68788-4159
Tizanidine hydrochloride 4 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-4159-1 | 6878841590168788415901 | 100 TABLET in 1 BOTTLE (68788-4159-1)Marketed from Jul 16, 2026 | |
| 68788-4159-2 | 6878841590268788415902 | 20 TABLET in 1 BOTTLE (68788-4159-2)Marketed from Jul 16, 2026 | |
| 68788-4159-3 | 6878841590368788415903 | 30 TABLET in 1 BOTTLE (68788-4159-3)Marketed from Jul 16, 2026 | |
| 68788-4159-6 | 6878841590668788415906 | 60 TABLET in 1 BOTTLE (68788-4159-6)Marketed from Jul 16, 2026 | |
| 68788-4159-8 | 6878841590868788415908 | 120 TABLET in 1 BOTTLE (68788-4159-8)Marketed from Jul 16, 2026 | |
| 68788-4159-9 | 6878841590968788415909 | 90 TABLET in 1 BOTTLE (68788-4159-9)Marketed from Jul 16, 2026 |
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
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218920
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 68788-4159_8d0b2b22-e1df-4ad5-92e6-f9a369108e4bSPL ID 8d0b2b22-e1df-4ad5-92e6-f9a369108e4bSPL set ID 8d0b2b22-e1df-4ad5-92e6-f9a369108e4bRxCUI 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
N468788415901followed by a unit qualifier and the quantityPackage 68788-4159-01. 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 indicated for the treatment of spasticity in adults. Tizanidine tablets are a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 68788-4159
- What is NDC 68788-4159?
- 68788-4159 is the product NDC for tizanidine, Tizanidine hydrochloride 4 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 6 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?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 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 |
| tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-658 | 64980-0658-0364980-0658-1064980-0658-15 |
Other NDCs under ANDA 218920
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 | Tizanidine hydrochloride 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-7716 |
| tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-658 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-659 |