Prescription drug · ANDA
Tizanidine Hydrochloride NDC 46708-491
Tizanidine hydrochloride 2 mg/1 · Capsule · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-491-08 | 46708049108 | 80 BLISTER PACK in 1 CARTON (46708-491-08) / 8 CAPSULE in 1 BLISTER PACKMarketed from Jan 15, 2020 | |
| 46708-491-30 | 46708049130 | 30 CAPSULE in 1 BOTTLE (46708-491-30)Marketed from Jan 15, 2020 | |
| 46708-491-41 | 46708049141 | 150 CAPSULE in 1 BOTTLE (46708-491-41)Marketed from Jan 15, 2020 | |
| 46708-491-91 | 46708049191 | 1000 CAPSULE in 1 BOTTLE (46708-491-91)Marketed from Jan 15, 2020 |
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 — 2 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213223
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 46708-491_cf7c5bb7-d94b-4c98-a4a2-e6a917e4165bSPL ID cf7c5bb7-d94b-4c98-a4a2-e6a917e4165bSPL set ID 29750221-497e-4747-a9b8-12a0c2236eaeRxCUI 485484, 485485, 485486UNII B53E3NMY5CUPC 0346708491307
- 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
N446708049108followed by a unit qualifier and the quantityPackage 46708-0491-08. 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 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 [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.
Other NDCs under ANDA 213223
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 Hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-493 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 2 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-491 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-492 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-493 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-492 |