Diltiazem hydrochloride
- Product NDC
- 63304-720
- 11-digit product format
- 633040720
- Labeler code
- 63304
- Product ID
- 63304-720_35b4a94c-9d26-e406-e063-6394a90aa9fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diltiazem hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA203023
- Marketing category
- ANDA
- Marketing start
- 2018-10-31
- Substance
- DILTIAZEM HYDROCHLORIDE
- Active strength
- 240 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 | 240 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 |
|---|
| 63304-720-05 | Diltiazem hydrochloride | 500 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 500 | | 10 |
| 63304-720-30 | Diltiazem hydrochloride | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 10 |
| 63304-720-90 | Diltiazem hydrochloride | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63304-720 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 10 | Current NDC, Legacy NDC, 3 package rows | 20250523_976d9dd0-4f11-4439-b84e-0c0f0e018d8b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63304-720-05 | 63304072005 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-720-05) | 2018-10-31 | 0000-00-00 | No | No | Current |
| 63304-720-30 | 63304072030 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-720-30) | 2018-10-31 | 0000-00-00 | No | No | Current |
| 63304-720-90 | 63304072090 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-720-90) | 2018-10-31 | 0000-00-00 | No | No | Current |