Diltiazem Hydrochloride
- Product NDC
- 60687-195
- 11-digit product format
- 606870195
- Labeler code
- 60687
- Product ID
- 60687-195_18597a1d-035b-fba0-e063-6294a90abecf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diltiazem Hydrochloride
- Dosage form
- CAPSULE, COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA074984
- Marketing category
- ANDA
- Marketing start
- 2016-11-16
- 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
- Brand name suffix
- Extended-Release
- 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 | 830801, 830837, 830845, 830861 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60687-195-01 | Diltiazem HydrochlorideExtended-Release | 100 in 1 BOX, UNIT-DOSE | CAPSULE, COATED, EXTENDED RELEAS | 100 | | 9 |
| 60687-195-11 | Diltiazem HydrochlorideExtended-Release | 1 in 1 BLISTER PACK | CAPSULE, COATED, EXTENDED RELEAS | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-195 | DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240514_11b43a17-8038-462b-8902-259431ad5256.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 |
|---|
| 60687-195-01 | 60687019501 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-195-01) / 1 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK (60687-195-11) | 100 blister pack | 2016-11-16 | 0000-00-00 | No | No | Current |
| 60687-195-11 | 60687019511 | 1 in 1 BLISTER PACK | | | | | | Historical |