Prescription drug · ANDA
Tizanidine NDC 68788-7991
Tizanidine hydrochloride 2 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)68788-7991Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-7991Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-7991-3 | 6878879910368788799103 | 30 TABLET in 1 BOTTLE (68788-7991-3)Marketed from Aug 6, 2021 | |
| 68788-7991-6 | 6878879910668788799106 | 60 TABLET in 1 BOTTLE (68788-7991-6)Marketed from Aug 6, 2021 | |
| 68788-7991-8 | 6878879910868788799108 | 120 TABLET in 1 BOTTLE (68788-7991-8)Marketed from Aug 6, 2021 | |
| 68788-7991-9 | 6878879910968788799109 | 90 TABLET in 1 BOTTLE (68788-7991-9)Marketed from Aug 6, 2021 |
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 — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- 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 68788-7991_99754101-fa6f-46e9-8b2f-a8b4e9f2458bSPL ID 99754101-fa6f-46e9-8b2f-a8b4e9f2458b
- 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
N468788799103followed by a unit qualifier and the quantityPackage 68788-7991-03. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 68788-7991
- What is NDC 68788-7991?
- 68788-7991 is the product NDC for Tizanidine, Tizanidine hydrochloride 2 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 4 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?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 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 2 mg/1 | TabletOral | NorthStar Rx LLC | 16714-171 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | NorthStar Rx LLC | 16714-172 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Quality Care Products, LLC | 35356-662 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-455 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-0811 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | A-S Medication Solutions | 50090-0840 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | A-S Medication Solutions | 50090-6756 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | A-S Medication Solutions | 50090-6757 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | AvPAK | 50268-759 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | AvPAK | 50268-760 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-603 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-179 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Dr. Reddy's Laboratories Limited | 55111-180 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-505 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-694 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Proficient Rx LP | 63187-009 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1673 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-3209 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Redpharm Drug | 67296-2263 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Redpharm Drug | 67296-2316 |
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