Tizanidine
- Product NDC
- 63187-673
- 11-digit product format
- 631870673
- Labeler code
- 63187
- Product ID
- 63187-673_2b2e33aa-55ad-4969-85d1-9cbfb62cabbb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tizanidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA076416
- Marketing category
- ANDA
- Marketing start
- 2003-12-11
- Substance
- TIZANIDINE HYDROCHLORIDE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 63187-673_2b2e33aa-55ad-4969-85d1-9cbfb62cabbb
- SPL ID
- 2b2e33aa-55ad-4969-85d1-9cbfb62cabbb
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Tizanidine
- Generic name
- Tizanidine
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2003-12-11
- Marketing category
- ANDA
- Application number
- ANDA076416
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA]; Central alpha-2 Adrenergic Agonist [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| TIZANIDINE HYDROCHLORIDE | 4 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | B53E3NMY5C |
| Rxcui | 313413 |
| Spl Set Id | 76dc85bd-3cde-4940-a99b-663b70bf9f54 |
| Manufacturer Name | Proficient Rx LP |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 63187-673-14 | 14 TABLET in 1 BOTTLE (63187-673-14) | 2022-01-05 | No |
| 63187-673-30 | 30 TABLET in 1 BOTTLE (63187-673-30) | 2018-12-01 | No |
| 63187-673-60 | 60 TABLET in 1 BOTTLE (63187-673-60) | 2018-12-01 | No |
| 63187-673-90 | 90 TABLET in 1 BOTTLE (63187-673-90) | 2018-12-01 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| B53E3NMY5C | TIZANIDINE HYDROCHLORIDE | 64461-82-1 | TIZANIDINE HYDROCHLORIDE |
| 6AI06C00GW | TIZANIDINE | 51322-75-9 | Tizanidine |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 63187-673-14 | 63187067314 | 14 TABLET in 1 BOTTLE (63187-673-14) | 14 tablet | 2022-01-05 | No | No | Historical |
| 63187-673-30 | 63187067330 | 30 TABLET in 1 BOTTLE (63187-673-30) | 30 tablet | 2018-12-01 | No | No | Historical |
| 63187-673-60 | 63187067360 | 60 TABLET in 1 BOTTLE (63187-673-60) | 60 tablet | 2018-12-01 | No | No | Historical |
| 63187-673-90 | 63187067390 | 90 TABLET in 1 BOTTLE (63187-673-90) | 90 tablet | 2018-12-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Tizanidine | Proficient Rx LP | 2022-03-01 | HUMAN PRESCRIPTION DRUG LABEL | 5 |