Diltiazem Hydrochloride
- Product NDC
- 82868-036
- 11-digit product format
- 828680036
- Labeler code
- 82868
- Product ID
- 82868-036_47f89c58-08d5-61d7-e063-6394a90a39a2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diltiazem hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA216521
- Marketing category
- ANDA
- Marketing start
- 2024-01-18
- 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
- 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 | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OLH94387TE |
| Rxcui | 833217 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82868-036-10 | Diltiazem Hydrochloride | 10 in 1 BOTTLE, PLASTIC | TABLET | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82868-036 | DILTIAZEM HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 1 | Current NDC, 1 package rows | 20240220_106b33e3-b199-e555-e063-6294a90a5af5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82868-036-10 | 82868003610 | 10 TABLET in 1 BOTTLE, PLASTIC (82868-036-10) | 10 tablet | 2024-01-18 | No | No | Historical |