Diltiazem Hydrochloride
- Product NDC
- 47335-673
- 11-digit product format
- 473350673
- Labeler code
- 47335
- Product ID
- 47335-673_ecddf1f1-b8e7-4a08-8f00-6cc484092a5f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diltiazem Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA090421
- Marketing category
- ANDA
- Marketing start
- 2010-11-15
- Substance
- DILTIAZEM HYDROCHLORIDE
- Active strength
- 360 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 | 360 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 |
|---|
| 47335-673-13 | Diltiazem Hydrochloride | 500 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 500 | | 11 |
| 47335-673-18 | Diltiazem Hydrochloride | 1000 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 1000 | | 11 |
| 47335-673-19 | Diltiazem Hydrochloride | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | | 11 |
| 47335-673-81 | Diltiazem Hydrochloride | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | | 11 |
| 47335-673-83 | Diltiazem Hydrochloride | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-673 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 11 | Current NDC, Legacy NDC, 5 package rows | 20230812_eebf29fe-ce22-4482-b850-5854550bf2c4.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 |
|---|
| 47335-673-13 | 47335067313 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-673-13) | 2010-11-15 | 0000-00-00 | No | No | Current |
| 47335-673-18 | 47335067318 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-673-18) | 2010-11-15 | 0000-00-00 | No | No | Current |
| 47335-673-19 | 47335067319 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-673-19) | 2010-11-15 | 0000-00-00 | No | No | Current |
| 47335-673-81 | 47335067381 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-673-81) | 2010-11-15 | 0000-00-00 | No | No | Current |
| 47335-673-83 | 47335067383 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-673-83) | 2010-11-15 | 0000-00-00 | No | No | Current |