tizanidine hydrochloride
- Product NDC
- 72789-507
- 11-digit product format
- 727890507
- Labeler code
- 72789
- Product ID
- 72789-507_3ba1fda2-ab86-5dd7-e063-6294a90a5364
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tizanidine hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA213798
- Marketing category
- ANDA
- Marketing start
- 2020-05-27
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| B53E3NMY5C | TIZANIDINE HYDROCHLORIDE | 64461-82-1 | TIZANIDINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-507-77 | 72789050777 | 150 CAPSULE in 1 BOTTLE, PLASTIC (72789-507-77) | 150 capsule | 2025-05-16 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| tizanidine hydrochloride | PD-Rx Pharmaceuticals, Inc. | 2025-08-05 | HUMAN PRESCRIPTION DRUG LABEL | 2 |