Diltiazem Hydrochloride
- Product NDC
- 68071-4005
- 11-digit product format
- 680714005
- Labeler code
- 68071
- Product ID
- 68071-4005_1d7a24e6-549e-9297-e063-6394a90a8372
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diltiazem Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA075116
- Marketing category
- ANDA
- Marketing start
- 1999-12-28
- 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 | 830837 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-4005-3 | 2024-07-17 | C162847 | 48780-1 | ba0f9c33-40dd-a910-e053-dadaa90a0b85 | DILTIAZEM HYDROCHLORIDE Extended-Release Capsules, USP |
| 68071-4005-9 | 2024-07-17 | C162847 | 48780-1 | ba0f9c33-40dd-a910-e053-dadaa90a0b85 | DILTIAZEM HYDROCHLORIDE Extended-Release Capsules, USP |
| 68071-4005-3 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-40dd-a910-e053-dadaa90a0b85 | DILTIAZEM HYDROCHLORIDE Extended-Release Capsules, USP |
| 68071-4005-9 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-40dd-a910-e053-dadaa90a0b85 | DILTIAZEM HYDROCHLORIDE Extended-Release Capsules, USP |
| 68071-4005-3 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-40dd-a910-e053-dadaa90a0b85 | DILTIAZEM HYDROCHLORIDE Extended-Release Capsules, USP |
| 68071-4005-9 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-40dd-a910-e053-dadaa90a0b85 | DILTIAZEM HYDROCHLORIDE Extended-Release Capsules, USP |
| 68071-4005-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-40dd-a910-e053-dadaa90a0b85 | DILTIAZEM HYDROCHLORIDE Extended-Release Capsules, USP |
| 68071-4005-9 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-40dd-a910-e053-dadaa90a0b85 | DILTIAZEM HYDROCHLORIDE Extended-Release Capsules, USP |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-4005-3 | Diltiazem Hydrochloride | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 3 |
| 68071-4005-9 | Diltiazem Hydrochloride | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4005 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240719_54b0b11d-adc0-4afb-e054-00144ff88e88.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 |
|---|
| 68071-4005-3 | 68071400503 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68071-4005-3) | 2017-07-19 | 0000-00-00 | No | No | Current |
| 68071-4005-9 | 68071400509 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68071-4005-9) | 2017-07-19 | 0000-00-00 | No | No | Current |