TEZRULY
- Product NDC
- 70954-592
- 11-digit product format
- 709540592
- Labeler code
- 70954
- Product ID
- 70954-592_0d2b0b80-5201-473a-9b43-f5c2127f6f7c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terazosin
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- NDA218139
- Marketing category
- NDA
- Marketing start
- 2025-04-18
- Substance
- TERAZOSIN HYDROCHLORIDE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TEZRULY
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TERAZOSIN HYDROCHLORIDE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D32S14F082 |
| Rxcui | 2689133, 2689139 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70954-592-10 | TEZRULY | 150 mL in 1 BOTTLE | SOLUTION | 150 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70954-592 | TEZRULY (TERAZOSIN) SOLUTION [ANI PHARMACEUTICALS, INC.] | 3 | Current NDC, 1 package rows | 20250419_69582e0c-6569-490c-8c14-999f3750336f.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 |
|---|
| 70954-592-10 | 70954059210 | 150 mL in 1 BOTTLE (70954-592-10) | 150 ml | 2025-04-18 | No | No | Current |