Katerzia
- Product NDC
- 52652-5001
- 11-digit product format
- 526525001
- Labeler code
- 52652
- Product ID
- 52652-5001_461e8d10-1805-e107-e063-6294a90aa288
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Azurity Pharmaceuticals, Inc.
- Application
- NDA211340
- Marketing category
- NDA
- Marketing start
- 2019-08-15
- Substance
- AMLODIPINE BENZOATE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [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
- Katerzia
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMLODIPINE BENZOATE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XD75TQ8A2P |
| Rxcui | 2184120, 2184126 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52652-5001-1 | Katerzia | 150 mL in 1 BOTTLE | SUSPENSION | 150 | | 7 |
| 52652-5001-1 | Katerzia | 1 in 1 CARTON | SUSPENSION | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52652-5001 | KATERZIA (AMLODIPINE) SUSPENSION [AZURITY PHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20230719_df673a4d-acb8-444c-a472-c87ab8cbd366.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 |
|---|
| 52652-5001-1 | 52652500101 | 1 BOTTLE in 1 CARTON (52652-5001-1) / 150 mL in 1 BOTTLE | 1 bottle | 2019-08-15 | 0000-00-00 | No | No | Current |