Diltiazem Hydrochloride Extended-Release
- Product NDC
- 75907-045
- 11-digit product format
- 759070045
- Labeler code
- 75907
- Product ID
- 75907-045_09bae4f6-ad9c-88db-a26b-3236e0f9022c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diltiazem Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Dr. Reddy's Labratories Inc.
- Application
- ANDA215775
- Marketing category
- ANDA
- Marketing start
- 2024-09-10
- Substance
- DILTIAZEM HYDROCHLORIDE
- Active strength
- 90 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 Extended-Release
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DILTIAZEM HYDROCHLORIDE | 90 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | OLH94387TE |
| Rxcui | 830865, 830869, 830872 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 61ebbccf-eedf-453b-940e-dba67b7a5fef | Product name | 4 | 20260107 |
| a8d6eaa3-afcc-47e5-be12-0c9251fc8740 | Product name | 1 | 20251124 |
| f6700316-a6ba-5e59-3413-8ede05ae58b9 | Product name | 7 | 20250625 |
| 8615f7a1-1e8f-8281-8601-d7a637926d1f | Product name | 4 | 20250522 |
| 3a9daa2f-bcd1-13de-a1b4-6172caa7f308 | Product name | 2 | 20240419 |
| f7129636-cba8-86c2-8bfb-9e2e2a9c7628 | Product name | 2 | 20240314 |
| 378290be-e30f-0e68-1201-165e93c337e8 | Product name | 3 | 20231212 |
| c733b56e-b0b5-4495-9857-0256a8242279 | Product name | 1 | 20220520 |
| f4df4721-60d9-7fd2-a665-5c3c9f55af81 | Product name | 2 | 20171003 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75907-045-01 | Diltiazem Hydrochloride Extended-Release | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 75907-045 | DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [DR. REDDY'S LABRATORIES INC.] | 1 | Current NDC, 1 package rows | 20240910_f1d09c53-5eb9-0b7c-e977-e2a602e84e5f.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 830872 | dilTIAZem hydrochloride 120 MG 12HR Extended Release Oral Capsule | PSN | f1d09c53-5eb9-0b7c-e977-e2a602e84e5f | 1 |
| 830872 | dilTIAZem hydrochloride 120 MG 12HR Extended Release Oral Capsule | PSN | 31e63a95-9e62-01c8-e063-6294a90af0e1 | 1 |
| 830865 | dilTIAZem hydrochloride 60 MG 12HR Extended Release Oral Capsule | PSN | f1d09c53-5eb9-0b7c-e977-e2a602e84e5f | 1 |
| 830865 | dilTIAZem hydrochloride 60 MG 12HR Extended Release Oral Capsule | PSN | 31e63a95-9e62-01c8-e063-6294a90af0e1 | 1 |
| 830869 | dilTIAZem hydrochloride 90 MG 12HR Extended Release Oral Capsule | PSN | f1d09c53-5eb9-0b7c-e977-e2a602e84e5f | 1 |
| 830869 | dilTIAZem hydrochloride 90 MG 12HR Extended Release Oral Capsule | PSN | 31e63a95-9e62-01c8-e063-6294a90af0e1 | 1 |
| 830872 | 12 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule | SCD | f1d09c53-5eb9-0b7c-e977-e2a602e84e5f | 1 |
| 830872 | 12 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule | SCD | 31e63a95-9e62-01c8-e063-6294a90af0e1 | 1 |
| 830865 | 12 HR diltiazem hydrochloride 60 MG Extended Release Oral Capsule | SCD | f1d09c53-5eb9-0b7c-e977-e2a602e84e5f | 1 |
| 830865 | 12 HR diltiazem hydrochloride 60 MG Extended Release Oral Capsule | SCD | 31e63a95-9e62-01c8-e063-6294a90af0e1 | 1 |
| 830869 | 12 HR diltiazem hydrochloride 90 MG Extended Release Oral Capsule | SCD | 31e63a95-9e62-01c8-e063-6294a90af0e1 | 1 |
| 830869 | 12 HR diltiazem hydrochloride 90 MG Extended Release Oral Capsule | SCD | f1d09c53-5eb9-0b7c-e977-e2a602e84e5f | 1 |
| 830872 | diltiazem hydrochloride 120 MG 12 HR Extended Release Oral Capsule | SY | f1d09c53-5eb9-0b7c-e977-e2a602e84e5f | 1 |
| 830872 | diltiazem hydrochloride 120 MG 12 HR Extended Release Oral Capsule | SY | 31e63a95-9e62-01c8-e063-6294a90af0e1 | 1 |
| 830865 | diltiazem hydrochloride 60 MG 12 HR Extended Release Oral Capsule | SY | 31e63a95-9e62-01c8-e063-6294a90af0e1 | 1 |
| 830865 | diltiazem hydrochloride 60 MG 12 HR Extended Release Oral Capsule | SY | f1d09c53-5eb9-0b7c-e977-e2a602e84e5f | 1 |
| 830869 | diltiazem hydrochloride 90 MG 12 HR Extended Release Oral Capsule | SY | f1d09c53-5eb9-0b7c-e977-e2a602e84e5f | 1 |
| 830869 | diltiazem hydrochloride 90 MG 12 HR Extended Release Oral Capsule | SY | 31e63a95-9e62-01c8-e063-6294a90af0e1 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 75907-045-01 | 75907004501 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (75907-045-01) | 2024-09-10 | No | No | Current |