Isradipine
- Product NDC
- 64850-910
- 11-digit product format
- 648500910
- Labeler code
- 64850
- Product ID
- 64850-910_194819ab-8bf2-4f80-b9bb-a1209af1ba21
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isradipine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Elite Laboratories, Inc.
- Application
- ANDA077169
- Marketing category
- ANDA
- Marketing start
- 2022-12-28
- Substance
- ISRADIPINE
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Isradipine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISRADIPINE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YO1UK1S598 |
| Rxcui | 197848, 197849 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64850-910-01 | Isradipine | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
| 64850-910-05 | Isradipine | 500 in 1 BOTTLE | CAPSULE | 500 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64850-910 | ISRADIPINE CAPSULE [ELITE LABORATORIES, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20221229_acf7c376-6cb6-4857-b455-0bf5da29346c.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 |
|---|
| 64850-910-01 | 64850091001 | 100 CAPSULE in 1 BOTTLE (64850-910-01) | 100 capsule | 2022-12-28 | 0000-00-00 | No | No | Current |
| 64850-910-05 | 64850091005 | 500 CAPSULE in 1 BOTTLE (64850-910-05) | 500 capsule | 2022-12-28 | 0000-00-00 | No | No | Current |