Tizanidine
- Product NDC
- 43353-914
- 11-digit product format
- 433530914
- Labeler code
- 43353
- Product ID
- 43353-914_39bfe789-da22-4c5e-ac9e-3e90f2ba1c21
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tizanidine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA076354
- Marketing category
- ANDA
- Marketing start
- 2003-05-06
- Marketing end
- 2021-02-28
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-914-16 | 43353091416 | 6000 TABLET in 1 BOTTLE, PLASTIC (43353-914-16) | 6000 tablet | 2014-03-28 | 2021-02-28 | No | No | Current |
| 43353-914-30 | 43353091430 | 30 TABLET in 1 BOTTLE, PLASTIC (43353-914-30) | 30 tablet | 2016-08-15 | 2021-02-28 | No | No | Current |
| 43353-914-53 | 43353091453 | 60 TABLET in 1 BOTTLE, PLASTIC (43353-914-53) | 60 tablet | 2016-08-15 | 2021-02-28 | No | No | Current |
| 43353-914-56 | 43353091456 | 3000 TABLET in 1 BOTTLE, PLASTIC (43353-914-56) | 3000 tablet | 2016-12-12 | 2021-02-28 | No | No | Current |
| 43353-914-60 | 43353091460 | 90 TABLET in 1 BOTTLE, PLASTIC (43353-914-60) | 90 tablet | 2016-08-15 | 2021-02-28 | No | No | Current |