Prescription drug · ANDA
Benzonatate NDC 0615-8403
Benzonatate 100 mg/1 · Capsule · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8403-05 | 00615840305 | 15 CAPSULE in 1 BLISTER PACK (0615-8403-05)Marketed from Jul 3, 2024 | |
| 0615-8403-21 | 00615840321 | 21 CAPSULE in 1 BLISTER PACK (0615-8403-21)Marketed from Feb 12, 2024 | |
| 0615-8403-39 | 00615840339 | 30 CAPSULE in 1 BLISTER PACK (0615-8403-39)Marketed from Oct 6, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091133
- Marketing start
- Marketing end
- Other FDA classes
- Decreased Tracheobronchial Stretch Receptor Activity (Physiologic effect)
- Identifiers
- Product ID 0615-8403_888d70d8-eda7-4bca-b78c-30fc56231abaSPL ID 888d70d8-eda7-4bca-b78c-30fc56231abaSPL set ID 6f5c19ad-d811-4196-a9c3-4f6b89626b83RxCUI 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
N400615840305followed by a unit qualifier and the quantityPackage 00615-8403-05. 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)
INDICATIONS AND USAGE Benzonatate capsules USP are indicated for the symptomatic relief of cough.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091133
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 | CapsuleOral | AvKARE | 42291-091 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | AvKARE | 42291-092 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-712 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-713 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | RedPharm Drug, Inc. | 67296-1464 |