Diltiazem Hydrochloride
- Product NDC
- 63629-7981
- 11-digit product format
- 636297981
- Labeler code
- 63629
- Product ID
- 63629-7981_b2aa9386-ca59-470e-871f-df6c7f2a6869
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diltiazem hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- NDA020401
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2014-08-20
- 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
- Brand name suffix
- EXTENDED RELEASE
- 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 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 63629-7981-1 | 2025-11-11 | C162847 | 48780-1 | 1030e365-4e1b-111a-e063-dadaa90a10e2 | Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only |
| 63629-7981-1 | 2025-11-11 | C162847 | 48780-1 | 1030e365-4e1b-111a-e063-dadaa90a10e2 | Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only |
| 63629-7981-2 | 2025-11-11 | C162847 | 48780-1 | 1030e365-4e1b-111a-e063-dadaa90a10e2 | Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only |
| 63629-7981-2 | 2025-11-11 | C162847 | 48780-1 | 1030e365-4e1b-111a-e063-dadaa90a10e2 | Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only |
| 63629-7981-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4e1b-111a-e063-dadaa90a10e2 | Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only |
| 63629-7981-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4e1b-111a-e063-dadaa90a10e2 | Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only |
| 63629-7981-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4e1b-111a-e063-dadaa90a10e2 | Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only |
| 63629-7981-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4e1b-111a-e063-dadaa90a10e2 | Diltiazem Hydrochloride Extended-Release Capsules, USP Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-7981-1 | Diltiazem HydrochlorideEXTENDED RELEASE | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 5 |
| 63629-7981-2 | Diltiazem HydrochlorideEXTENDED RELEASE | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-7981 | DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 4 | Current NDC, Legacy NDC, 2 package rows | 20220203_58eeb8bc-91d0-4cf8-a0d7-be3548d92196.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 |
|---|
| 63629-7981-1 | 63629798101 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-7981-1) | 2019-04-02 | 0000-00-00 | No | No | Current |
| 63629-7981-2 | 63629798102 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-7981-2) | 2022-02-02 | 0000-00-00 | No | No | Current |