Prescription drug · ANDA
Amlodipine Besylate and Benazepril Hydrochloride NDC 50090-5357
Amlodipine besylate 5 mg/1; Benazepril hydrochloride 40 mg/1 · Capsule · Oral · A-S Medication Solutions
NDC codes
FDA NDC DirectoryProduct NDC (as listed)50090-5357Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-5357Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5357-0 | 5009053570050090535700 | 90 CAPSULE in 1 BOTTLE (50090-5357-0)Marketed from Nov 12, 2020 |
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)
- Amlodipine Besylate and Benazepril Hydrochloride
- Generic name (nonproprietary)
- amlodipine besylate and benazepril hydrochloride
- Active ingredients
- Amlodipine besylate — 5 mg/1Benazepril hydrochloride — 40 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078466
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin-converting Enzyme Inhibitors (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Decreased Blood Pressure (Physiologic effect)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 50090-5357_2257a49f-9ed5-4f2a-b543-9946f3570f0bSPL ID 2257a49f-9ed5-4f2a-b543-9946f3570f0bSPL set ID c695f95d-6064-4a22-84ba-c8e62477b3a7RxCUI 898359UNII 864V2Q084H, N1SN99T69T
- Pharmacologic class
- Angiotensin Converting Enzyme Inhibitor; 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
N450090535700followed by a unit qualifier and the quantityPackage 50090-5357-00. 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 and benazepril hydrochloride capsule, is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting-enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsule, is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent ( 1 ). 1.1 Hypertension Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
Excerpt only. Read the full label for complete information.
About NDC 50090-5357
- What is NDC 50090-5357?
- 50090-5357 is the product NDC for Amlodipine Besylate and Benazepril Hydrochloride, Amlodipine besylate 5 mg/1; Benazepril hydrochloride 40 mg/1 capsule, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amlodipine Besylate and Benazepril Hydrochloride.
- What is the active ingredient?
- Amlodipine besylate, Benazepril hydrochloride.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. 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 and Benazepril Hydrochloride?
- 47 other product NDCs are listed under this name. See all Amlodipine Besylate and Benazepril Hydrochloride 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 and Benazepril Hydrochloride 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 and Benazepril Hydrochloride | Amlodipine besylate 2.5 mg/1; Benazepril hydrochloride 10 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-2684 | 69238-2684-01 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 10 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-2685 | 69238-2685-01 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-2686 | 69238-2686-01 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 10 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-2687 | 69238-2687-01 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 10 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4499 | 70518-4499-00 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4386 | 70518-4386-00 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 40 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4388 | 70518-4388-00 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 10 mg/1; Benazepril hydrochloride 40 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4382 | 70518-4382-00 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 10 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8818 | 68788-8818-03 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 10 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-041 | 82868-0041-90 |
All 48 Amlodipine Besylate and Benazepril Hydrochloride NDCs
Other NDCs under ANDA 078466
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 and Benazepril Hydrochloride | Amlodipine besylate 10 mg/1; Benazepril hydrochloride 40 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5389 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 10 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5404 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6185 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 10 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6427 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 10 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-130 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 10 mg/1; Benazepril hydrochloride 40 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-131 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 2.5 mg/1; Benazepril hydrochloride 10 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-132 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 10 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-133 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-134 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 40 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-135 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-459 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 40 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-463 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 10 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-472 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 10 mg/1; Benazepril hydrochloride 40 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-473 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 2.5 mg/1; Benazepril hydrochloride 10 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-755 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 10 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-756 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-757 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 10 mg/1; Benazepril hydrochloride 20 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-758 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 5 mg/1; Benazepril hydrochloride 40 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-759 |
| Amlodipine Besylate and Benazepril Hydrochloride | Amlodipine besylate 10 mg/1; Benazepril hydrochloride 40 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-760 |
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