Diltiazem Hydrochloride
- Product NDC
- 48433-032
- 11-digit product format
- 484330032
- Labeler code
- 48433
- Product ID
- 48433-032_49eef6c8-e1fc-86af-e063-6294a90a0309
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diltiazem hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Safecor Health LLC
- Application
- ANDA074910
- Marketing category
- ANDA
- Marketing start
- 2026-02-02
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diltiazem Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DILTIAZEM HYDROCHLORIDE | 120 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 |
|---|---|---|---|---|---|---|
| 48433-032-01 | Diltiazem Hydrochloride | 1 in 1 BLISTER PACK | CAPSULE, EXTENDED RELEASE | 1 | 2 | |
| 48433-032-20 | Diltiazem Hydrochloride | 100 in 1 CARTON | CAPSULE, EXTENDED RELEASE | 100 | 2 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 830872 | dilTIAZem hydrochloride 120 MG 12HR Extended Release Oral Capsule | PSN | fc02db0f-5311-4b61-896e-bfe340832735 | 2 |
| 830865 | dilTIAZem hydrochloride 60 MG 12HR Extended Release Oral Capsule | PSN | fc02db0f-5311-4b61-896e-bfe340832735 | 2 |
| 830869 | dilTIAZem hydrochloride 90 MG 12HR Extended Release Oral Capsule | PSN | fc02db0f-5311-4b61-896e-bfe340832735 | 2 |
| 830872 | 12 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule | SCD | fc02db0f-5311-4b61-896e-bfe340832735 | 2 |
| 830865 | 12 HR diltiazem hydrochloride 60 MG Extended Release Oral Capsule | SCD | fc02db0f-5311-4b61-896e-bfe340832735 | 2 |
| 830869 | 12 HR diltiazem hydrochloride 90 MG Extended Release Oral Capsule | SCD | fc02db0f-5311-4b61-896e-bfe340832735 | 2 |
| 830872 | diltiazem hydrochloride 120 MG 12 HR Extended Release Oral Capsule | SY | fc02db0f-5311-4b61-896e-bfe340832735 | 2 |
| 830865 | diltiazem hydrochloride 60 MG 12 HR Extended Release Oral Capsule | SY | fc02db0f-5311-4b61-896e-bfe340832735 | 2 |
| 830869 | diltiazem hydrochloride 90 MG 12 HR Extended Release Oral Capsule | SY | fc02db0f-5311-4b61-896e-bfe340832735 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 48433-032-01 | 48433003201 | 1 in 1 BLISTER PACK | Historical | ||||
| 48433-032-20 | 48433003220 | 100 BLISTER PACK in 1 CARTON (48433-032-20) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (48433-032-01) | 100 blister pack | 2026-02-02 | No | No | Current |