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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- tizanidine hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TIZANIDINE HYDROCHLORIDE | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | B53E3NMY5C |
| Rxcui | 485485 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-507-77 | tizanidine hydrochloride | 150 in 1 BOTTLE, PLASTIC | CAPSULE | 150 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-507 | TIZANIDINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20250519_d7d5dce0-f8a2-404d-9e87-e2235f5d3268.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |