Prescription drug · ANDA
Tizanidine NDC 70518-1598
Tizanidine hydrochloride 4 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-1598-1 | 7051815980170518159801 | 60 TABLET in 1 BOTTLE, PLASTIC (70518-1598-1)Marketed from Aug 1, 2019 | |
| 70518-1598-3 | 7051815980370518159803 | 30 TABLET in 1 BOTTLE, PLASTIC (70518-1598-3)Marketed from Mar 6, 2020 | |
| 70518-1598-4 | 7051815980470518159804 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-1598-4)Marketed from Apr 3, 2020 |
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)
- Tizanidine
- Generic name (nonproprietary)
- tizanidine
- Active ingredients
- Tizanidine hydrochloride — 4 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- 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 70518-1598_561da0d9-88b4-95d0-e063-6394a90ac769SPL ID 561da0d9-88b4-95d0-e063-6394a90ac769SPL set ID b14bd166-9f53-4f2e-be05-c447af04ef69RxCUI 313413UNII 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
N470518159801followed by a unit qualifier and the quantityPackage 70518-1598-01. 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 is a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. ( 1 ) Tizanidine is indicated for the treatment of spasticity in adults.
Excerpt only. Read the full label for complete information.
About NDC 70518-1598
- What is NDC 70518-1598?
- 70518-1598 is the product NDC for Tizanidine, Tizanidine hydrochloride 4 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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 | Proficient Rx LP | 63187-910 |
| 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 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 |