Prescription drug · ANDA
Benzonatate NDC 65162-537
Benzonatate 200 mg/1 · Capsule, Liquid filled · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-537-10 | 65162053710 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-537-10)Marketed from Jun 4, 2010 | |
| 65162-537-50 | 65162053750 | 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-537-50)Marketed from Jun 4, 2010 |
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)
- Benzonatate
- Generic name (nonproprietary)
- benzonatate
- Active ingredients
- Benzonatate — 200 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040682
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Tracheobronchial Stretch Receptor Activity (Physiologic effect)
- Identifiers
- Product ID 65162-537_72b0f799-3f8f-4dcf-9c6e-57e796996a80SPL ID 72b0f799-3f8f-4dcf-9c6e-57e796996a80SPL set ID 199a42ae-4d19-4e68-934d-dabd27084988RxCUI 197397, 283417UNII 5P4DHS6ENRUPC 0365162537505, 0365162536508
- Pharmacologic class
- Non-narcotic Antitussive
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
N465162053710followed by a unit qualifier and the quantityPackage 65162-0537-10. 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)
INDICATIONS AND USAGE Benzonatate is indicated for the symptomatic relief of cough.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040682
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 |
|---|---|---|---|---|
| Benzonatate | Benzonatate 100 mg/1 | Capsule, Liquid filledOral | Amneal Pharmaceuticals LLC | 65162-536 |
| Benzonatate | Benzonatate 200 mg/1 | Capsule, Liquid filledOral | Bryant Ranch Prepack | 71335-3169 |
| Benzonatate | Benzonatate 200 mg/1 | Capsule, Liquid filledOral | Redpharm Drug | 67296-2202 |
| Benzonatate | Benzonatate 100 mg/1 | Capsule, Liquid filledOral | Redpharm Drug | 67296-2207 |
| Benzonatate | Benzonatate 100 mg/1 | Capsule, Liquid filledOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-898 |
| Benzonatate | Benzonatate 200 mg/1 | Capsule, Liquid filledOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-899 |
| Benzonatate | Benzonatate 100 mg/1 | Capsule, Liquid filledOral | Proficient Rx LP | 63187-076 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-441 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-440 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2021 |