Prescription drug · ANDA
Tizanidine Hydrochloride NDC 68788-8747
Tizanidine hydrochloride 4 mg/1 · Capsule · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8747-1 | 6878887470168788874701 | 100 CAPSULE in 1 BOTTLE, PLASTIC (68788-8747-1)Marketed from Sep 26, 2024 | |
| 68788-8747-2 | 6878887470268788874702 | 20 CAPSULE in 1 BOTTLE, PLASTIC (68788-8747-2)Marketed from Sep 26, 2024 | |
| 68788-8747-3 | 6878887470368788874703 | 30 CAPSULE in 1 BOTTLE, PLASTIC (68788-8747-3)Marketed from Sep 26, 2024 | |
| 68788-8747-6 | 6878887470668788874706 | 60 CAPSULE in 1 BOTTLE, PLASTIC (68788-8747-6)Marketed from Sep 26, 2024 | |
| 68788-8747-8 | 6878887470868788874708 | 120 CAPSULE in 1 BOTTLE, PLASTIC (68788-8747-8)Marketed from Sep 26, 2024 | |
| 68788-8747-9 | 6878887470968788874709 | 90 CAPSULE in 1 BOTTLE, PLASTIC (68788-8747-9)Marketed from Sep 26, 2024 |
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 — 4 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210267
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 68788-8747_7881a67b-18b9-4f98-b953-fe8ed7748645SPL ID 7881a67b-18b9-4f98-b953-fe8ed7748645
- 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
N468788874701followed by a unit qualifier and the quantityPackage 68788-8747-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 68788-8747
- What is NDC 68788-8747?
- 68788-8747 is the product NDC for Tizanidine Hydrochloride, Tizanidine hydrochloride 4 mg/1 capsule, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 6 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?
- 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 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 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 |
| tizanidine hydrochloride | Tizanidine hydrochloride 2 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-506 | 72789-0506-77 |
Other NDCs under ANDA 210267
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 6 mg/1 | CapsuleOral | Direct_Rx | 72189-526 |
| Tizanidine HCL | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0090 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 2 mg/1 | CapsuleOral | Ingenus Pharmaceuticals, LLC | 50742-224 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 4 mg/1 | CapsuleOral | Ingenus Pharmaceuticals, LLC | 50742-225 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Ingenus Pharmaceuticals, LLC | 50742-226 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-892 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8478 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-9743 |
| Tizanidine Hydrochloride | Tizanidine hydrochloride 6 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0448 |