Prescription drug · ANDA
tizanidine NDC 76420-885
Tizanidine hydrochloride 2 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-885-00 | 7642008850076420088500 | 1000 TABLET in 1 BOTTLE (76420-885-00)Marketed from Dec 27, 2024 | |
| 76420-885-01 | 7642008850176420088501 | 100 TABLET in 1 BOTTLE (76420-885-01)Marketed from Dec 27, 2024 | |
| 76420-885-11 | 7642008851176420088511 | 10 TABLET in 1 BLISTER PACK (76420-885-11)Marketed from Dec 27, 2024 | |
| 76420-885-15 | 7642008851576420088515 | 15 TABLET in 1 BOTTLE (76420-885-15)Marketed from Dec 27, 2024 | |
| 76420-885-21 | 7642008852176420088521 | 150 TABLET in 1 BOTTLE (76420-885-21)Marketed from Dec 27, 2024 | |
| 76420-885-30 | 7642008853076420088530 | 30 TABLET in 1 BOTTLE (76420-885-30)Marketed from Dec 27, 2024 | |
| 76420-885-60 | 7642008856076420088560 | 60 TABLET in 1 BOTTLE (76420-885-60)Marketed from Dec 27, 2024 | |
| 76420-885-88 | 7642008858876420088588 | 10 TABLET in 1 BOTTLE (76420-885-88)Marketed from Dec 27, 2024 | |
| 76420-885-90 | 7642008859076420088590 | 90 TABLET in 1 BOTTLE (76420-885-90)Marketed from Dec 27, 2024 | |
| 76420-885-99 | 7642008859976420088599 | 10 BLISTER PACK in 1 CARTON (76420-885-99) / 10 TABLET in 1 BLISTER PACKMarketed from Dec 27, 2024 |
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 — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Asclemed USA, Inc.NDC labeler code 76420
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208187
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 76420-885_2a395a10-4c73-4213-e063-6394a90abb25SPL ID 2a395a10-4c73-4213-e063-6394a90abb25SPL set ID a9ba9023-0c3f-4c9b-ba8e-d39d23bf35d6RxCUI 313412, 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
N476420088500followed by a unit qualifier and the quantityPackage 76420-0885-00. 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 a central alpha-2-adrenergic agonist indicated for the treatment of spasticity. ( 1 ) Tizanidine tablets are indicated for the treatment of spasticity in adults.
Excerpt only. Read the full label for complete information.
About NDC 76420-885
- What is NDC 76420-885?
- 76420-885 is the product NDC for tizanidine, Tizanidine hydrochloride 2 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 10 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?
- Asclemed USA, Inc., NDC labeler code 76420. 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 208187
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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8468 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8469 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Coupler LLC | 67046-1444 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3719 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4181 |
| tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1335 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1336 |
| tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-096 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-097 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-886 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0436 |
| Tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0453 |
| tizanidine | Tizanidine hydrochloride 4 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0454 |
| tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0500 |