Diltiazem Hydrochloride
- Product NDC
- 47335-679
- 11-digit product format
- 473350679
- Labeler code
- 47335
- Product ID
- 47335-679_3c94f868-93d3-4b36-8420-b2903a0bd79a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diltiazem Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA090492
- Marketing category
- ANDA
- Marketing start
- 2011-10-31
- Substance
- DILTIAZEM HYDROCHLORIDE
- Active strength
- 360 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]
- 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, 830801, 830837, 830845, 830861 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-679-13 | Diltiazem Hydrochloride | 500 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 500 | | 8 |
| 47335-679-18 | Diltiazem Hydrochloride | 1000 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 1000 | | 8 |
| 47335-679-19 | Diltiazem Hydrochloride | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | | 8 |
| 47335-679-81 | Diltiazem Hydrochloride | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | | 8 |
| 47335-679-83 | Diltiazem Hydrochloride | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 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 [SUN PHARMA GLOBAL FZE] | 4 | |
| DILTIAZEM | ACTIVE MOIETY | EE92BBP03H | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 4 | |
| ACETYLTRIBUTYL CITRATE | INACTIVE INGREDIENT | 0ZBX0N59RZ | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 4 | |
| AMMONIO METHACRYLATE COPOLYMER TYPE B | INACTIVE INGREDIENT | 161H3B14U2 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 4 | |
| ETHYLCELLULOSE (20 MPA.S) | INACTIVE INGREDIENT | BJG0S321QY | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 4 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 4 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 4 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 4 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 4 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 4 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-679 | DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 8 | Current NDC, Legacy NDC, 5 package rows | 20230115_6f71ba5e-7bd6-409a-80c6-2f22d975aefc.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 |
|---|
| 47335-679-13 | 47335067913 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-679-13) | 2011-10-31 | 0000-00-00 | No | No | Current |
| 47335-679-18 | 47335067918 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-679-18) | 2011-10-31 | 0000-00-00 | No | No | Current |
| 47335-679-19 | 47335067919 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-679-19) | 2011-10-31 | 0000-00-00 | No | No | Current |
| 47335-679-81 | 47335067981 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-679-81) | 2011-10-31 | 0000-00-00 | No | No | Current |
| 47335-679-83 | 47335067983 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-679-83) | 2011-10-31 | 0000-00-00 | No | No | Current |