Prescription drug · ANDA
Tizanidine NDC 63187-910
Tizanidine hydrochloride 2 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-910-30 | 6318709103063187091030 | 30 TABLET in 1 BOTTLE, PLASTIC (63187-910-30)Marketed from Sep 1, 2017 | |
| 63187-910-60 | 6318709106063187091060 | 60 TABLET in 1 BOTTLE, PLASTIC (63187-910-60)Marketed from Sep 1, 2017 | |
| 63187-910-90 | 6318709109063187091090 | 90 TABLET in 1 BOTTLE, PLASTIC (63187-910-90)Marketed from Sep 1, 2017 |
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
- Generic name (nonproprietary)
- tizanidine
- Active ingredients
- Tizanidine hydrochloride — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091283
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 63187-910_fdcb382b-4753-45e8-ab3c-28d929c764b7SPL ID fdcb382b-4753-45e8-ab3c-28d929c764b7SPL set ID 5b7b4721-e6fa-4586-ac40-091ad363ee85RxCUI 313412UNII B53E3NMY5CUPC 0363187910303
- 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
N463187091030followed by a unit qualifier and the quantityPackage 63187-0910-30. 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 is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important. ( 1 ) Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration ( 2.1 )] .
Excerpt only. Read the full label for complete information.
About NDC 63187-910
- What is NDC 63187-910?
- 63187-910 is the product NDC for Tizanidine, Tizanidine hydrochloride 2 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tizanidine.
- What is the active ingredient?
- Tizanidine hydrochloride.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 63187. 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?
- 110 other product NDCs are listed under this name. See all Tizanidine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tizanidine 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 | Tizanidine hydrochloride 2 mg/1 | TabletOral | Aurobindo Pharma Limited | 84386-023 | 84386-0023-7784386-0023-99 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Aurobindo Pharma Limited | 84386-024 | 84386-0024-7784386-0024-99 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4159 | 68788-4159-0168788-4159-0268788-4159-03+3 more |
| Tizanidine | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Direct_Rx | 72189-678 | 72189-0678-30 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Medcore LLC | 82461-720 | 82461-0720-60 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Medcore LLC | 82461-721 | 82461-0721-60 |
| tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0500 | 80425-0500-0180425-0500-0280425-0500-03 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8802 | 68788-8802-0168788-8802-0268788-8802-03+3 more |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Direct_rx | 72189-602 | 72189-0602-3072189-0602-6072189-0602-90 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Direct_rx | 72189-599 | 72189-0599-3072189-0599-6072189-0599-82+1 more |
Other NDCs under ANDA 091283
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 |
|---|---|---|---|---|
| Tizandine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Direct_Rx | 61919-811 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-168 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-169 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-868 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-2078 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | A-S Medication Solutions | 50090-5767 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | A-S Medication Solutions | 50090-7889 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Proficient Rx LP | 63187-493 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Redpharm Drug | 67296-2209 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4463 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8802 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1598 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0424 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0914 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-228 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0187 |
| Tizanidine HCL | Tizanidine hydrochloride 4 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0024 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 4 mg/1 | TabletOral | TIZANIDINE HYDROCHLORIDE | 61919-196 |