Prescription drug · ANDA
Tizanidine Hydrochloride NDC 76420-902
Tizanidine hydrochloride 6 mg/1 · Capsule · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-902-01 | 7642009020176420090201 | 1 BLISTER PACK in 1 CARTON (76420-902-01) / 10 CAPSULE in 1 BLISTER PACKMarketed from Jan 28, 2025 | |
| 76420-902-05 | 7642009020576420090205 | 500 CAPSULE in 1 BOTTLE (76420-902-05)Marketed from Jan 28, 2025 | |
| 76420-902-10 | 7642009021076420090210 | 10 CAPSULE in 1 BOTTLE (76420-902-10)Marketed from Jan 28, 2025 | |
| 76420-902-15 | 7642009021576420090215 | 150 CAPSULE in 1 BOTTLE (76420-902-15)Marketed from Jan 28, 2025 | |
| 76420-902-20 | 7642009022076420090220 | 20 CAPSULE in 1 BOTTLE (76420-902-20)Marketed from Jan 28, 2025 | |
| 76420-902-30 | 7642009023076420090230 | 30 CAPSULE in 1 BOTTLE (76420-902-30)Marketed from Jan 28, 2025 | |
| 76420-902-60 | 7642009026076420090260 | 60 CAPSULE in 1 BOTTLE (76420-902-60)Marketed from Jan 28, 2025 | |
| 76420-902-90 | 7642009029076420090290 | 90 CAPSULE in 1 BOTTLE (76420-902-90)Marketed from Jan 28, 2025 |
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 — 6 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Asclemed USA, Inc.NDC labeler code 76420
- 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 76420-902_4647720a-9159-6041-e063-6294a90a54f1SPL ID 4647720a-9159-6041-e063-6294a90a54f1SPL set ID 07b8db58-d037-477e-a62f-025e8a5afcb4RxCUI 485484, 485485, 485486UNII 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
N476420090201followed by a unit qualifier and the quantityPackage 76420-0902-01. 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.
About NDC 76420-902
- What is NDC 76420-902?
- 76420-902 is the product NDC for Tizanidine Hydrochloride, Tizanidine hydrochloride 6 mg/1 capsule, listed with the FDA by Asclemed USA, Inc.. It has 8 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tizanidine Hydrochloride.
- What is the active ingredient?
- Tizanidine hydrochloride.
- Who is the labeler?
- Asclemed USA, Inc., NDC labeler code 76420. 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 Hydrochloride?
- 54 other product NDCs are listed under this name. See all Tizanidine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tizanidine 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) |
|---|---|---|---|---|---|
| Tizanidine Hydrochloride | Tizanidine hydrochloride 8 mg/1 | CapsuleOral | Trifluent Pharma, LLC | 73352-089 | 73352-0089-60 |
| tizanidine hydrochloride | Tizanidine hydrochloride 8 mg/1 | CapsuleOral | Advagen Pharma Limited | 72888-161 | 72888-0161-15 |
| tizanidine hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0474 | 80425-0474-0180425-0474-0280425-0474-03+1 more |
| tizanidine hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8776 | 68788-8776-0168788-8776-0268788-8776-03+3 more |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0448 | 80425-0448-0180425-0448-0280425-0448-03 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8747 | 68788-8747-0168788-8747-0268788-8747-03+3 more |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8478 | 68788-8478-0168788-8478-0368788-8478-06+1 more |
| tizanidine hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2559 | 71335-2559-0171335-2559-0271335-2559-03+1 more |
| tizanidine hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2872 | 71335-2872-0171335-2872-0271335-2872-03+2 more |
| tizanidine hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-505 | 72789-0505-77 |
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 |
| 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 4 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8798 |
| 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 |