Prescription drug · ANDA
Tizanidine NDC 63629-3209
Tizanidine hydrochloride 2 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-3209-0 | 6362932090063629320900 | 40 TABLET in 1 BOTTLE (63629-3209-0)Marketed from Dec 8, 2021 | |
| 63629-3209-1 | 6362932090163629320901 | 30 TABLET in 1 BOTTLE (63629-3209-1)Marketed from Aug 24, 2007 | |
| 63629-3209-2 | 6362932090263629320902 | 60 TABLET in 1 BOTTLE (63629-3209-2)Marketed from Apr 25, 2007 | |
| 63629-3209-3 | 6362932090363629320903 | 90 TABLET in 1 BOTTLE (63629-3209-3)Marketed from Mar 6, 2007 | |
| 63629-3209-4 | 6362932090463629320904 | 120 TABLET in 1 BOTTLE (63629-3209-4)Marketed from Sep 17, 2008 | |
| 63629-3209-5 | 6362932090563629320905 | 100 TABLET in 1 BOTTLE (63629-3209-5)Marketed from Oct 13, 2008 | |
| 63629-3209-6 | 6362932090663629320906 | 84 TABLET in 1 BOTTLE (63629-3209-6)Marketed from Mar 4, 2010 | |
| 63629-3209-7 | 6362932090763629320907 | 28 TABLET in 1 BOTTLE (63629-3209-7)Marketed from Mar 4, 2010 | |
| 63629-3209-8 | 6362932090863629320908 | 21 TABLET in 1 BOTTLE (63629-3209-8)Marketed from Nov 17, 2010 | |
| 63629-3209-9 | 6362932090963629320909 | 160 TABLET in 1 BOTTLE (63629-3209-9)Marketed from Aug 1, 2011 |
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
- Bryant Ranch PrepackNDC labeler code 63629
- 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 63629-3209_82084f4e-00d0-c298-c13a-88a6c0860b02SPL ID 82084f4e-00d0-c298-c13a-88a6c0860b02SPL set ID 82084f4e-00d0-c298-c13a-88a6c0860b02RxCUI 313412UNII 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
N463629320900followed by a unit qualifier and the quantityPackage 63629-3209-00. 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 tablet is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine tablets should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration ( 2.1 ) ]. Tizanidine tablet is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine tablet should be reserved for those daily activities and times when relief of spasticity is most important. (1)
Excerpt only. Read the full label for complete information.
About NDC 63629-3209
- What is NDC 63629-3209?
- 63629-3209 is the product NDC for Tizanidine, Tizanidine hydrochloride 2 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 4 mg/1 | TabletOral | Redpharm Drug | 67296-2263 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | Redpharm Drug | 67296-2316 |
| Tizanidine | Tizanidine hydrochloride 2 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3440 |
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