Terazosin hydrochloride
- Product NDC
- 68788-9815
- 11-digit product format
- 687889815
- Labeler code
- 68788
- Product ID
- 68788-9815_1aad6bb0-ce5d-45bb-afe1-4b37e22cb761
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terazosin hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc
- Application
- ANDA075317
- Marketing category
- ANDA
- Marketing start
- 2012-04-05
- Substance
- TERAZOSIN HYDROCHLORIDE
- Active strength
- 5 mg/1
- 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
- Terazosin hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TERAZOSIN HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D32S14F082 |
| Rxcui | 313215, 313217, 313219 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-9815-1 | Terazosin hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 10 |
| 68788-9815-3 | Terazosin hydrochloride | 30 in 1 BOTTLE | CAPSULE | 30 | | 10 |
| 68788-9815-6 | Terazosin hydrochloride | 60 in 1 BOTTLE | CAPSULE | 60 | | 10 |
| 68788-9815-9 | Terazosin hydrochloride | 90 in 1 BOTTLE | CAPSULE | 90 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Terazosin hydrochloride | ACTIVE INGREDIENT | D32S14F082 | TERAZOSIN HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| Terazosin | ACTIVE MOIETY | 8L5014XET7 | TERAZOSIN HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| D&c Red No. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | TERAZOSIN HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| D&c Yellow No. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | TERAZOSIN HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| Ferrosoferric Oxide | INACTIVE INGREDIENT | XM0M87F357 | TERAZOSIN HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| Gelatin | INACTIVE INGREDIENT | 2G86QN327L | TERAZOSIN HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| Lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | TERAZOSIN HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| Magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | TERAZOSIN HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TERAZOSIN HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| Sodium lauryl sulfate | INACTIVE INGREDIENT | 368GB5141J | TERAZOSIN HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | TERAZOSIN HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-9815 | TERAZOSIN HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC] | 9 | Current NDC, Legacy NDC, 4 package rows | 20240820_9d8fd052-b478-447e-a884-74fcd21275bb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-9815-1 | 68788981501 | 100 CAPSULE in 1 BOTTLE (68788-9815-1) | 100 capsule | 2012-04-05 | 0000-00-00 | No | No | Current |
| 68788-9815-3 | 68788981503 | 30 CAPSULE in 1 BOTTLE (68788-9815-3) | 30 capsule | 2012-04-05 | 0000-00-00 | No | No | Current |
| 68788-9815-6 | 68788981506 | 60 CAPSULE in 1 BOTTLE (68788-9815-6) | 60 capsule | 2012-04-05 | 0000-00-00 | No | No | Current |
| 68788-9815-9 | 68788981509 | 90 CAPSULE in 1 BOTTLE (68788-9815-9) | 90 capsule | 2012-04-05 | 0000-00-00 | No | No | Current |