Prescription drug · ANDA
Benzonatate NDC 63187-076
Benzonatate 100 mg/1 · Capsule, Liquid filled · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-076-14 | 63187007614 | 14 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-076-14)Marketed from Nov 1, 2018 | |
| 63187-076-20 | 63187007620 | 20 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-076-20)Marketed from Nov 1, 2018 | |
| 63187-076-30 | 63187007630 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-076-30)Marketed from Nov 1, 2018 | |
| 63187-076-40 | 63187007640 | 40 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-076-40)Marketed from Nov 1, 2018 |
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 — 100 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Proficient Rx LP
- 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 63187-076_1e43585a-8e75-4a75-a011-56b5f80cb7cdSPL ID 1e43585a-8e75-4a75-a011-56b5f80cb7cdSPL set ID 19f1e761-69e9-4330-ad3c-1f1180d70cb0RxCUI 197397UNII 5P4DHS6ENR
- 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
N463187007614followed by a unit qualifier and the quantityPackage 63187-0076-14. 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 | Amneal Pharmaceuticals LLC | 65162-537 |
| 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 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 |