Diltiazem Hydrochloride
- Product NDC
- 50228-481
- 11-digit product format
- 502280481
- Labeler code
- 50228
- Product ID
- 50228-481_31a9f85e-b3f0-4b39-a133-8d4324df2aff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diltiazem hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals, Inc
- Application
- ANDA216521
- Marketing category
- ANDA
- Marketing start
- 2022-09-26
- Substance
- DILTIAZEM HYDROCHLORIDE
- Active strength
- 30 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 | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OLH94387TE |
| Rxcui | 831054, 831102, 831103, 833217 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50228-481-01 | Diltiazem Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 50228-481-05 | Diltiazem Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
| 50228-481-10 | Diltiazem Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 3 |
| 50228-481-30 | Diltiazem Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50228-481 | DILTIAZEM HYDROCHLORIDE TABLET DILTIAZEM HYDROCHLORIDE TABLET [SCIEGEN PHARMACEUTICALS, INC] | 2 | Current NDC, Legacy NDC, 4 package rows | 20230124_196fc367-330e-4d15-b1d6-084ad3f97ae7.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 |
|---|
| 50228-481-01 | 50228048101 | 100 TABLET in 1 BOTTLE (50228-481-01) | 100 tablet | 2022-09-26 | | No | No | Current |
| 50228-481-05 | 50228048105 | 500 TABLET in 1 BOTTLE (50228-481-05) | 500 tablet | 2022-09-26 | | No | No | Current |
| 50228-481-10 | 50228048110 | 1000 TABLET in 1 BOTTLE (50228-481-10) | 1000 tablet | 2022-09-26 | 0000-00-00 | No | No | Current |
| 50228-481-30 | 50228048130 | 30 TABLET in 1 BOTTLE (50228-481-30) | 30 tablet | 2022-09-26 | 0000-00-00 | No | No | Current |