diltiazem hydrochloride
- Product NDC
- 68382-595
- 11-digit product format
- 683820595
- Labeler code
- 68382
- Product ID
- 68382-595_3683dc39-602e-463a-b04a-6d066d2fe94d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diltiazem hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA206534
- Marketing category
- ANDA
- Marketing start
- 2017-09-28
- Substance
- DILTIAZEM HYDROCHLORIDE
- Active strength
- 120 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- diltiazem hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DILTIAZEM HYDROCHLORIDE | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OLH94387TE |
| Rxcui | 830795, 830801, 830837, 830845, 830861 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-595-01 | diltiazem hydrochloride | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | | 6 |
| 68382-595-05 | diltiazem hydrochloride | 500 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 500 | | 6 |
| 68382-595-06 | diltiazem hydrochloride | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 6 |
| 68382-595-16 | diltiazem hydrochloride | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | | 6 |
| 68382-595-30 | diltiazem hydrochloride | 10 in 1 BLISTER PACK | CAPSULE, EXTENDED RELEASE | 10 | | 6 |
| 68382-595-77 | diltiazem hydrochloride | 10 in 1 CARTON | CAPSULE, EXTENDED RELEASE | 10 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-595 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 6 | Current NDC, Legacy NDC, 6 package rows | 20250502_1e2f2025-0350-40c4-ab42-3b57f3d105a6.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 |
|---|
| 68382-595-01 | 68382059501 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-595-01) | | 2017-09-28 | 0000-00-00 | No | No | Current |
| 68382-595-05 | 68382059505 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-595-05) | | 2018-10-02 | 0000-00-00 | No | No | Current |
| 68382-595-06 | 68382059506 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-595-06) | | 2017-09-28 | 0000-00-00 | No | No | Current |
| 68382-595-16 | 68382059516 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-595-16) | | 2017-09-28 | 0000-00-00 | No | No | Current |
| 68382-595-30 | 68382059530 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 68382-595-77 | 68382059577 | 10 BLISTER PACK in 1 CARTON (68382-595-77) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-595-30) | 10 blister pack | 2017-09-28 | 0000-00-00 | No | No | Current |