Prescription drug · ANDA
Amlodipine, Valsartan, Hydrochlorothiazide NDC 64380-201
amlodipine besylate valsartan hydrochlorothiazide · Amlodipine besylate 10 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-201-01 | 6438002010164380020101 | 30 TABLET, FILM COATED in 1 BOTTLE (64380-201-01)Marketed from Jun 27, 2022 | |
| 64380-201-02 | 6438002010264380020102 | 90 TABLET, FILM COATED in 1 BOTTLE (64380-201-02)Marketed from Jun 27, 2022 | |
| 64380-201-03 | 6438002010364380020103 | 500 TABLET, FILM COATED in 1 BOTTLE (64380-201-03)Marketed from Jun 27, 2022 |
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, Valsartan, Hydrochlorothiazide
- Generic name (nonproprietary)
- amlodipine besylate valsartan hydrochlorothiazide
- Active ingredients
- Amlodipine besylate — 10 mg/1Hydrochlorothiazide — 25 mg/1Valsartan — 320 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Strides Pharma Science LimitedNDC labeler code 64380
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201087
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 64380-201_6c98cab6-e7ba-42ba-adf9-71fa67c0a403SPL ID 6c98cab6-e7ba-42ba-adf9-71fa67c0a403SPL set ID 9b76e441-e6a5-4036-8276-b7788ade5c44RxCUI 848131, 848135, 848140, 848145, 848151UNII 80M03YXJ7I, 0J48LPH2TH, 864V2Q084HUPC 0364380197010, 0364380199014, 0364380200017, 0364380201014
- Pharmacologic class
- Angiotensin 2 Receptor Blocker; Calcium Channel Blocker; Dihydropyridine Calcium Channel Blocker; Thiazide Diuretic
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
N464380020101followed by a unit qualifier and the quantityPackage 64380-0201-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Amlodipine/valsartan/hydrochlorothiazide 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine, hydrochlorothiazide, and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine/valsartan/hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, l…
Excerpt only. Read the full label for complete information.
About NDC 64380-201
- What is NDC 64380-201?
- 64380-201 is the product NDC for Amlodipine, Valsartan, Hydrochlorothiazide, Amlodipine besylate 10 mg/1 + 2 more ingredients tablet, film coated, listed with the FDA by Strides Pharma Science Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amlodipine, Valsartan, Hydrochlorothiazide (Amlodipine besylate valsartan hydrochlorothiazide).
- What is the active ingredient?
- Amlodipine besylate, Hydrochlorothiazide, Valsartan.
- Who is the labeler?
- Strides Pharma Science Limited, NDC labeler code 64380. 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, Valsartan, Hydrochlorothiazide?
- 9 other product NDCs are listed under this name. See all Amlodipine, Valsartan, Hydrochlorothiazide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Amlodipine, Valsartan, Hydrochlorothiazide 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, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-197 | 64380-0197-0164380-0197-0264380-0197-03 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-198 | 64380-0198-0164380-0198-0264380-0198-03 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-199 | 64380-0199-0164380-0199-0264380-0199-03 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-200 | 64380-0200-0164380-0200-0264380-0200-03 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-668 | 51407-0668-30 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-669 | 51407-0669-30 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-670 | 51407-0670-30 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-671 | 51407-0671-30 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-672 | 51407-0672-30 |
Other NDCs under ANDA 201087
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, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-199 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-197 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-198 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Strides Pharma Science Limited | 64380-200 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-669 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 5 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-668 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-672 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-670 |
| Amlodipine, Valsartan, Hydrochlorothiazideamlodipine besylate valsartan hydrochlorothiazide | Amlodipine besylate 10 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-671 |