Diltiazem Hydrochloride
- Product NDC
- 50090-0451
- 11-digit product format
- 500900451
- Labeler code
- 50090
- Product ID
- 50090-0451_6113069e-e767-42d1-a59a-5001924df02c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diltiazem Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA074185
- Marketing category
- ANDA
- Marketing start
- 1995-12-22
- Substance
- DILTIAZEM HYDROCHLORIDE
- Active strength
- 60 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 table| Ingredient | Strength |
|---|
| DILTIAZEM HYDROCHLORIDE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OLH94387TE |
| Rxcui | 831103 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-0451-0 | Diltiazem Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 19 |
| 50090-0451-2 | Diltiazem Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 19 |
| 50090-0451-3 | Diltiazem Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-0451 | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 17 | Current NDC, Legacy NDC, 3 package rows | 20231002_e99e1446-9c85-478c-9e23-a5f4104bbd22.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 |
|---|
| 50090-0451-0 | 50090045100 | 100 TABLET, FILM COATED in 1 BOTTLE (50090-0451-0) | 2018-10-25 | 0000-00-00 | No | No | Current |
| 50090-0451-2 | 50090045102 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-0451-2) | 2016-06-29 | 0000-00-00 | No | No | Current |
| 50090-0451-3 | 50090045103 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-0451-3) | 2018-05-16 | 0000-00-00 | No | No | Current |