Prescription drug · NDA
Katerzia (Amlodipine) NDC 52652-5001
Amlodipine benzoate 1 mg/mL · Suspension · Oral · Azurity Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52652-5001-1 | 52652500101 | 1 BOTTLE in 1 CARTON (52652-5001-1) / 150 mL in 1 BOTTLEMarketed from Aug 15, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Katerzia
- Generic name (nonproprietary)
- amlodipine
- Active ingredients
- Amlodipine benzoate — 1 mg/mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Azurity Pharmaceuticals, Inc.NDC labeler code 52652
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211340
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 52652-5001_461e8d10-1805-e107-e063-6294a90aa288SPL ID 461e8d10-1805-e107-e063-6294a90aa288SPL set ID df673a4d-acb8-444c-a472-c87ab8cbd366RxCUI 2184120, 2184126UNII XD75TQ8A2P
- Pharmacologic class
- Calcium Channel Blocker; Dihydropyridine Calcium Channel Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N452652500101followed by a unit qualifier and the quantityPackage 52652-5001-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
KATERZIA is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: Hypertension ( 1.1 ) KATERZIA is indicated for the treatment of hypertension in adults and children 6 years and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Coronary Artery Disease ( 1.2 ) Chronic Stable Angina Vasospastic Angina (Prinzmetal’s or Variant Angina) Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%. 1.1 Hypertension KATERZIA is indicated for the tre…
Excerpt only. Read the full label for complete information.
About NDC 52652-5001
- What is NDC 52652-5001?
- 52652-5001 is the product NDC for Katerzia (amlodipine), Amlodipine benzoate 1 mg/mL suspension, listed with the FDA by Azurity Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Katerzia (Amlodipine).
- What is the active ingredient?
- Amlodipine benzoate.
- Who is the labeler?
- Azurity Pharmaceuticals, Inc., NDC labeler code 52652. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Katerzia?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.