Prescription drug · ANDA
tizanidine hydrochloride NDC 70771-1069
Tizanidine hydrochloride 6 mg/1 · Capsule · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1069-4 | 7077110690470771106904 | 10 BLISTER PACK in 1 CARTON (70771-1069-4) / 10 CAPSULE in 1 BLISTER PACKMarketed from Apr 27, 2017 | |
| 70771-1069-5 | 7077110690570771106905 | 500 CAPSULE in 1 BOTTLE (70771-1069-5)Marketed from Apr 27, 2017 | |
| 70771-1069-8 | 7077110690870771106908 | 150 CAPSULE in 1 BOTTLE (70771-1069-8)Marketed from Apr 27, 2017 |
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 hydrochloride
- Generic name (nonproprietary)
- tizanidine hydrochloride
- Active ingredients
- Tizanidine hydrochloride — 6 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208622
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 70771-1069_e5aa06ec-9ceb-4c1c-9334-90bef0d9366fSPL ID e5aa06ec-9ceb-4c1c-9334-90bef0d9366fSPL set ID 5f4889d1-1387-4c90-9b76-00beda3c1683RxCUI 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
N470771106904followed by a unit qualifier and the quantityPackage 70771-1069-04. 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 capsules are a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. ( 1 ) Tizanidine capsules are indicated for the treatment of spasticity in adults.
Excerpt only. Read the full label for complete information.
About NDC 70771-1069
- What is NDC 70771-1069?
- 70771-1069 is the product NDC for tizanidine hydrochloride, Tizanidine hydrochloride 6 mg/1 capsule, listed with the FDA by Zydus Lifesciences Limited. It has 3 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?
- Zydus Lifesciences Limited, NDC labeler code 70771. 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 208622
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 2 mg/1 | CapsuleOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1111 |
| tizanidine hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1112 |
| tizanidine hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1113 |
| tizanidine hydrochloride | Tizanidine hydrochloride 2 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1067 |
| tizanidine hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1068 |