Prescription drug · ANDA
Tizanidine NDC 60760-505
Tizanidine hydrochloride 4 mg/1 · Tablet · Oral · St. Mary's Medical Park Pharmacy
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60760-505-04 | 60760050504 | 4 TABLET in 1 BOTTLE, PLASTIC (60760-505-04)Marketed from Oct 4, 2021 | |
| 60760-505-15 | 60760050515 | 15 TABLET in 1 BOTTLE, PLASTIC (60760-505-15)Marketed from Jun 21, 2021 | |
| 60760-505-30 | 60760050530 | 30 TABLET in 1 BOTTLE, PLASTIC (60760-505-30)Marketed from Jul 30, 2021 | |
| 60760-505-60 | 60760050560 | 60 TABLET in 1 BOTTLE, PLASTIC (60760-505-60)Marketed from Nov 10, 2021 | |
| 60760-505-90 | 60760050590 | 90 TABLET in 1 BOTTLE, PLASTIC (60760-505-90)Marketed from Dec 8, 2021 |
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 — 4 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- St. Mary's Medical Park PharmacyNDC labeler code 60760
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076286
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 60760-505_549e550c-f294-576d-e063-6294a90a4184SPL ID 549e550c-f294-576d-e063-6294a90a4184SPL set ID c6b4486f-e847-64ee-e053-2995a90a855aRxCUI 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
N460760050504followed by a unit qualifier and the quantityPackage 60760-0505-04. 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 tablets are indicated for the treatment of spasticity in adults. Tizanidine tablet is a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 60760-505
- What is NDC 60760-505?
- 60760-505 is the product NDC for Tizanidine, Tizanidine hydrochloride 4 mg/1 tablet, listed with the FDA by St. Mary's Medical Park Pharmacy. It has 5 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?
- St. Mary's Medical Park Pharmacy, NDC labeler code 60760. 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 4 mg/1 | TabletOral | Aurobindo Pharma Limited | 84386-024 | 84386-0024-7784386-0024-99 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Aurobindo Pharma Limited | 84386-023 | 84386-0023-7784386-0023-99 |
| 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 4 mg/1 | TabletOral | Medcore LLC | 82461-721 | 82461-0721-60 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Medcore LLC | 82461-720 | 82461-0720-60 |
| 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 076286
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 | Tizanidine hydrochloride 4 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-603 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | American Health Packaging | 68084-645 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 4 mg/1 | TabletOral | Quality Care Products LLC | 49999-347 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | American Health Packaging | 68084-775 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5268 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-455 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-865 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-866 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3440 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1673 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Proficient Rx LP | 63187-009 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Redpharm Drug | 67296-2263 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | AvPAK | 50268-760 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | HAWAII REPACK, INC. | 85534-0029 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | HAWAII REPACK, INC. | 85534-0030 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | AvPAK | 50268-759 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Quality Care Products, LLC | 35356-662 |
| Tizanidine HCl | Tizanidine hydrochloride 2 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0425 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7781 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-228 |
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