Prescription drug · ANDA
Tizanidine Hydrochloride NDC 62332-491
Tizanidine hydrochloride 2 mg/1 · Capsule · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-491-08 | 62332049108 | 80 BLISTER PACK in 1 CARTON (62332-491-08) / 8 CAPSULE in 1 BLISTER PACKMarketed from Jan 15, 2020 | |
| 62332-491-30 | 62332049130 | 30 CAPSULE in 1 BOTTLE (62332-491-30)Marketed from Jan 15, 2020 | |
| 62332-491-41 | 62332049141 | 150 CAPSULE in 1 BOTTLE (62332-491-41)Marketed from Jan 15, 2020 | |
| 62332-491-91 | 62332049191 | 1000 CAPSULE in 1 BOTTLE (62332-491-91)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
- Labeler
- Alembic Pharmaceuticals Inc.
- 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 62332-491_451990b5-d759-4025-9373-59f12ab8c267SPL ID 451990b5-d759-4025-9373-59f12ab8c267SPL set ID ee3e9813-a738-46d1-9c05-c931aee1495cRxCUI 485484, 485485, 485486UNII B53E3NMY5CUPC 0362332491308, 0362332493302, 0362332492305
- 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
N462332049108followed by a unit qualifier and the quantityPackage 62332-0491-08. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 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 2 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-491 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-492 |