Isradipine
- Product NDC
- 16252-539
- 11-digit product format
- 162520539
- Labeler code
- 16252
- Product ID
- 16252-539_ac19e8fb-dc66-4e27-8109-d9ac5bf9b8e9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isradipine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA077317
- Marketing category
- ANDA
- Marketing start
- 2004-01-05
- 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 |
|---|
| 16252-539-01 | Isradipine | 100 in 1 BOTTLE | CAPSULE | 100 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ISRADIPINE | ACTIVE INGREDIENT | YO1UK1S598 | ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] | 4 | |
| ISRADIPINE | ACTIVE MOIETY | YO1UK1S598 | ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] | 4 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] | 4 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] | 4 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] | 4 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] | 4 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ISRADIPINE CAPSULE [ACTAVIS PHARMA, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16252-539 | ISRADIPINE CAPSULE [TEVA PHARMACEUTICALS USA, INC.] | 10 | Current NDC, Legacy NDC, 1 package rows | 20241122_bf3425e0-428d-4bdb-ac9a-3b9d483df83a.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 |
|---|
| 16252-539-01 | 16252053901 | 100 CAPSULE in 1 BOTTLE (16252-539-01) | 100 capsule | 2004-01-05 | 0000-00-00 | No | No | Current |