Diltiazem Hydrochloride
- Product NDC
- 0228-2918
- 11-digit product format
- 002282918
- Labeler code
- 0228
- Product ID
- 0228-2918_3bfa9909-89ed-47d3-8e01-0c688a59a093
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diltiazem Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA202463
- Marketing category
- ANDA
- Marketing start
- 2013-11-25
- 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
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0228-2918-09 | Diltiazem Hydrochloride | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | | 9 |
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 [ACTAVIS ELIZABETH LLC] | 2 | |
| DILTIAZEM | ACTIVE MOIETY | EE92BBP03H | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 2 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 2 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | INACTIVE INGREDIENT | 74G4R6TH13 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 2 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) | INACTIVE INGREDIENT | 5KY68S2577 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 2 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 2 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 2 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0228-2918 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20220204_178eec1f-1d4d-4a38-b66a-d3ba3de06c3d.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 |
|---|
| 0228-2918-09 | 00228291809 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-2918-09) | 2013-11-25 | 0000-00-00 | No | No | Current |