Prescription drug · ANDA
Tizanidne hydrochloride NDC 68788-8798
Tizanidine hydrochloride 4 mg/1 · Capsule · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8798-1 | 6878887980168788879801 | 100 CAPSULE in 1 BOTTLE (68788-8798-1)Marketed from Jan 1, 2025 | |
| 68788-8798-2 | 6878887980268788879802 | 20 CAPSULE in 1 BOTTLE (68788-8798-2)Marketed from Jan 1, 2025 | |
| 68788-8798-3 | 6878887980368788879803 | 30 CAPSULE in 1 BOTTLE (68788-8798-3)Marketed from Jan 1, 2025 | |
| 68788-8798-6 | 6878887980668788879806 | 60 CAPSULE in 1 BOTTLE (68788-8798-6)Marketed from Jan 1, 2025 | |
| 68788-8798-8 | 6878887980868788879808 | 120 CAPSULE in 1 BOTTLE (68788-8798-8)Marketed from Jan 1, 2025 | |
| 68788-8798-9 | 6878887980968788879809 | 90 CAPSULE in 1 BOTTLE (68788-8798-9)Marketed from Jan 1, 2025 |
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)
- Tizanidne hydrochloride
- Generic name (nonproprietary)
- tizanidne hydrochloride
- Active ingredients
- Tizanidine hydrochloride — 4 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212196
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 68788-8798_ff9d2f6a-8654-4dbe-ab07-4f9cacda54aeSPL ID ff9d2f6a-8654-4dbe-ab07-4f9cacda54aeSPL set ID 3f569c5a-ec9d-4356-ac04-c17714ff68d1RxCUI 485485UNII 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
N468788879801followed by a unit qualifier and the quantityPackage 68788-8798-01. 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 capsules are indicated for the treatment of spasticity in adults. Tizanidine capsules 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 68788-8798
- What is NDC 68788-8798?
- 68788-8798 is the product NDC for Tizanidne hydrochloride, Tizanidine hydrochloride 4 mg/1 capsule, 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?
- Tizanidne hydrochloride.
- 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 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.
Related NDCs: other Tizanidne hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| 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 |
| Tizanidne hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2210 | 71335-2210-01 |
Other NDCs under ANDA 212196
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 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 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 |
| Tizanidne hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-231 |