DILTIAZEM HYDROCHLORIDE
- Product NDC
- 60505-0016
- 11-digit product format
- 605050016
- Labeler code
- 60505
- Product ID
- 60505-0016_e06c5d5f-878e-6bb1-793c-642751592404
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DILTIAZEM HYDROCHLORIDE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA074943
- Marketing category
- ANDA
- Marketing start
- 2001-07-30
- 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, 830845, 830861, 831215, 831252, 831285 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60505-0016-6 | DILTIAZEM HYDROCHLORIDE | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | | 8 |
| 60505-0016-8 | DILTIAZEM HYDROCHLORIDE | 500 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 500 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DILTIAZEM HYDROCHLORIDE | ACTIVE INGREDIENT | OLH94387TE | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 3 | |
| DILTIAZEM | ACTIVE MOIETY | EE92BBP03H | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 3 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-0016 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240926_56573e9d-7bd2-694c-cd6d-26039590e548.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 |
|---|
| 60505-0016-6 | 60505001606 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-0016-6) | 2001-07-30 | 0000-00-00 | No | No | Current |
| 60505-0016-8 | 60505001608 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-0016-8) | 2001-07-30 | 0000-00-00 | No | No | Current |