Prescription drug · ANDA
Benzonatate NDC 67877-573
Benzonatate 100 mg/1 · Capsule · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-573-01 | 67877057301 | 100 CAPSULE in 1 BOTTLE (67877-573-01)Marketed from Mar 22, 2017 | |
| 67877-573-05 | 67877057305 | 500 CAPSULE in 1 BOTTLE (67877-573-05)Marketed from Mar 22, 2017 |
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
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040627
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Tracheobronchial Stretch Receptor Activity (Physiologic effect)
- Identifiers
- Product ID 67877-573_c4c367db-c1ef-4b68-b373-987b36e51f50SPL ID c4c367db-c1ef-4b68-b373-987b36e51f50SPL set ID 54374c04-63b9-49fa-b6a2-4a711e322d8eRxCUI 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
N467877057301followed by a unit qualifier and the quantityPackage 67877-0573-01. 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 & USAGE Benzonatate USP is indicated for the symptomatic relief of cough.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040627
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 | Proficient Rx LP | 71205-971 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-575 |
| benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0688 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-776 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Coupler LLC | 67046-1629 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | QPharma, Inc. | 42708-082 |
| benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Proficient Rx LP | 63187-928 |
| benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1329 |