Prescription drug · ANDA
Tizanidne hydrochloride NDC 71335-2077
Tizanidine hydrochloride 6 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2077-1 | 71335207701 | 30 CAPSULE in 1 BOTTLE (71335-2077-1)Marketed from Apr 25, 2022 | |
| 71335-2077-2 | 71335207702 | 60 CAPSULE in 1 BOTTLE (71335-2077-2)Marketed from Apr 25, 2022 | |
| 71335-2077-3 | 71335207703 | 90 CAPSULE in 1 BOTTLE (71335-2077-3)Marketed from Apr 25, 2022 | |
| 71335-2077-4 | 71335207704 | 120 CAPSULE in 1 BOTTLE (71335-2077-4)Marketed from Apr 25, 2022 | |
| 71335-2077-5 | 71335207705 | 28 CAPSULE in 1 BOTTLE (71335-2077-5)Marketed from Apr 25, 2022 |
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 — 6 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- 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 71335-2077_7938cb0f-644d-41cf-a0c9-34984db47d44SPL ID 7938cb0f-644d-41cf-a0c9-34984db47d44SPL set ID 649f1f76-da33-4bdf-a38d-5ae3a9cb7987RxCUI 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
N471335207701followed by a unit qualifier and the quantityPackage 71335-2077-01. 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 hydrochloride is indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride 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 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 |
|---|---|---|---|---|
| Tizanidne hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-231 |
| Tizanidine HCL | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0144 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-901 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 2 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-900 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-902 |
| Tizanidne hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8798 |
| Tizanidne hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8872 |
| Tizanidne hydrochloride | Tizanidine hydrochloride 2 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8871 |
| Tizanidne hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8873 |
| Tizanidne hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1862 |
| 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 | 71335-2210 |
| 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 | Ascend Laboratories, LLC | 67877-612 |
| 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 |