Diltiazem Hydrochloride
- Product NDC
- 51079-926
- 11-digit product format
- 510790926
- Labeler code
- 51079
- Product ID
- 51079-926_3a39f795-b54d-4e0b-e063-6294a90ae2a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diltiazem hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Institutional Inc.
- Application
- ANDA074910
- Marketing category
- ANDA
- Marketing start
- 1999-12-15
- 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
- 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 | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OLH94387TE |
| Rxcui | 830865, 830869, 830872 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51079-926-01 | Diltiazem Hydrochloride | 1 in 1 BLISTER PACK | CAPSULE, EXTENDED RELEASE | 1 | | 10 |
| 51079-926-20 | Diltiazem Hydrochloride | 100 in 1 CARTON | CAPSULE, EXTENDED RELEASE | 100 | | 10 |
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 [MYLAN INSTITUTIONAL INC.] | 2 | |
| DILTIAZEM | ACTIVE MOIETY | EE92BBP03H | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 2 | |
| DIETHYL PHTHALATE | INACTIVE INGREDIENT | UF064M00AF | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 2 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 2 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 2 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) | INACTIVE INGREDIENT | 5KY68S2577 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51079-926 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20230404_9942f1a2-f66d-4d9e-9794-49bee8abf5ab.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51079-926-01 | 51079092601 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 51079-926-20 | 51079092620 | 100 BLISTER PACK in 1 CARTON (51079-926-20) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (51079-926-01) | 100 blister pack | 1999-12-15 | 0000-00-00 | No | No | Current |