tizanidine hydrochloride
- Product NDC
- 55289-784
- 11-digit product format
- 552890784
- Labeler code
- 55289
- Product ID
- 55289-784_e9abb2df-0b93-3850-e053-2a95a90abc7e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tizanidine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA076280
- Marketing category
- ANDA
- Marketing start
- 2002-06-27
- Marketing end
- 2022-09-30
- 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 |
|---|
| 55289-784-20 | 55289078420 | 20 TABLET in 1 BOTTLE, PLASTIC (55289-784-20) | 20 tablet | 2004-04-16 | 0000-00-00 | No | No | Current |
| 55289-784-30 | 55289078430 | 30 TABLET in 1 BOTTLE, PLASTIC (55289-784-30) | 30 tablet | 2007-06-20 | 0000-00-00 | No | No | Current |
| 55289-784-60 | 55289078460 | 60 TABLET in 1 BOTTLE, PLASTIC (55289-784-60) | 60 tablet | 2006-03-08 | 0000-00-00 | No | No | Current |
| 55289-784-90 | 55289078490 | 90 TABLET in 1 BOTTLE, PLASTIC (55289-784-90) | 90 tablet | 2007-11-13 | 0000-00-00 | No | No | Current |