diltiazem hydrochloride
- Product NDC
- 70518-3484
- 11-digit product format
- 705183484
- Labeler code
- 70518
- Product ID
- 70518-3484_4f1d1966-bc81-e48b-e063-6294a90ad352
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diltiazem hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA208783
- Marketing category
- ANDA
- Marketing start
- 2022-08-19
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- diltiazem hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DILTIAZEM HYDROCHLORIDE | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OLH94387TE |
| Rxcui | 830861 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3484-0 | diltiazem hydrochloride | 30 in 1 BLISTER PACK | CAPSULE, EXTENDED RELEASE | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3484 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250423_5e935265-d0fc-4223-835f-72426eeea6c4.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 |
|---|
| 70518-3484-0 | 70518348400 | 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-3484-0) | 2022-08-19 | 0000-00-00 | No | No | Current |