Diltiazem Hydrochloride
- Product NDC
- 46708-727
- 11-digit product format
- 467080727
- Labeler code
- 46708
- Product ID
- 46708-727_063fdd2a-2532-45c6-8bb1-318064ff77bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diltiazem Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA216968
- Marketing category
- ANDA
- Marketing start
- 2024-11-14
- 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 |
|---|
| 46708-727-30 | Diltiazem Hydrochloride | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 4 |
| 46708-727-90 | Diltiazem Hydrochloride | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | | 4 |
| 46708-727-91 | Diltiazem Hydrochloride | 1000 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 1000 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-727 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED] | 4 | Current NDC, 3 package rows | 20241228_d9c5c1ed-1a9d-494c-b798-9da09ba1fe1b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-727-30 | 46708072730 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-727-30) | 2024-11-14 | No | No | Current |
| 46708-727-90 | 46708072790 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-727-90) | 2024-11-14 | No | No | Current |
| 46708-727-91 | 46708072791 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-727-91) | 2024-11-14 | No | No | Current |