Prescription drug · ANDA
Benzonatate NDC 42291-091
Benzonatate 100 mg/1 · Capsule · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-091-01 | 42291009101 | 100 CAPSULE in 1 BOTTLE (42291-091-01)Marketed from Nov 29, 2023 | |
| 42291-091-50 | 42291009150 | 500 CAPSULE in 1 BOTTLE (42291-091-50)Marketed from Nov 29, 2023 |
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
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091133
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Tracheobronchial Stretch Receptor Activity (Physiologic effect)
- Identifiers
- Product ID 42291-091_485b7ac3-8e97-f7a7-e063-6294a90a8138SPL ID 485b7ac3-8e97-f7a7-e063-6294a90a8138SPL set ID 0b50405c-d399-edcd-e063-6294a90a89c2RxCUI 197397, 283417UNII 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
N442291009101followed by a unit qualifier and the quantityPackage 42291-0091-01. 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 .
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 | Strides Pharma Science Limited | 64380-712 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-713 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8403 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | AvKARE | 42291-092 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | RedPharm Drug, Inc. | 67296-1464 |