Prescription drug · ANDA
Amlodipine Besylate NDC 43489-101
Amlodipine besylate 10 mg/1 · Tablet · Oral · China Resources Saike Pharmaceutical Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43489-101-01 | 4348901010143489010101 | 90 TABLET in 1 BOTTLE, PLASTIC (43489-101-01)Marketed from May 23, 2016 | |
| 43489-101-03 | 4348901010343489010103 | 500 TABLET in 1 BOTTLE, PLASTIC (43489-101-03)Marketed from May 23, 2016 | |
| 43489-101-05 | 4348901010543489010105 | 1000 TABLET in 1 BOTTLE, PLASTIC (43489-101-05)Marketed from May 23, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Amlodipine Besylate
- Generic name (nonproprietary)
- amlodipine besylate
- Active ingredients
- Amlodipine besylate — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- China Resources Saike Pharmaceutical Co., Ltd.NDC labeler code 43489
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090752
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 43489-101_53c969a7-d151-97a6-e063-6394a90ae408SPL ID 53c969a7-d151-97a6-e063-6394a90ae408SPL set ID 3518853a-4c5b-4161-a178-8da7f656f009RxCUI 197361, 308135, 308136UNII 864V2Q084H
- 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
N443489010101followed by a unit qualifier and the quantityPackage 43489-0101-01. 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)
Amlodipine 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 ) Amlodipine is indicated for the treatment of hypertension, 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 Amlodipine is indicated for the treatment of hypertension, to lower bloo…
Excerpt only. Read the full label for complete information.
About NDC 43489-101
- What is NDC 43489-101?
- 43489-101 is the product NDC for Amlodipine Besylate, Amlodipine besylate 10 mg/1 tablet, listed with the FDA by China Resources Saike Pharmaceutical Co., Ltd.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amlodipine Besylate.
- What is the active ingredient?
- Amlodipine besylate.
- Who is the labeler?
- China Resources Saike Pharmaceutical Co., Ltd., NDC labeler code 43489. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Amlodipine Besylate?
- 167 other product NDCs are listed under this name. See all Amlodipine Besylate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Amlodipine Besylate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | American Health Packaging | 60687-961 | 60687-0961-01 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | American Health Packaging | 60687-972 | 60687-0972-01 |
| Amlodipine Besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | Direct_Rx | 72189-689 | 72189-0689-90 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Coupler LLC | 67046-1157 | 67046-1157-03 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-016 | 87441-0016-01 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-017 | 87441-0017-01 |
| Amlodipine Besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | Safecor Health LLC | 48433-155 | 48433-0155-20 |
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | Safecor Health LLC | 48433-156 | 48433-0156-20 |
| Amlodipine Besylate | Amlodipine besylate 10 mg/1 | TabletOral | Safecor Health LLC | 48433-157 | 48433-0157-20 |
| Amlodipine Besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4629 | 70518-4629-0070518-4629-02 |
Other NDCs under ANDA 090752
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Amlodipine Besylate | Amlodipine besylate 5 mg/1 | TabletOral | China Resources Saike Pharmaceutical Co., Ltd. | 43489-100 |
| Amlodipine Besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | China Resources Saike Pharmaceutical Co., Ltd. | 43489-102 |