Prescription drug · ANDA
Benzonatate NDC 71610-692
Benzonatate 100 mg/1 · Capsule · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-692-30 | 71610069230 | 30 CAPSULE in 1 BOTTLE, PLASTIC (71610-692-30)Marketed from Mar 10, 2023 | |
| 71610-692-53 | 71610069253 | 60 CAPSULE in 1 BOTTLE, PLASTIC (71610-692-53)Marketed from Mar 10, 2023 | |
| 71610-692-60 | 71610069260 | 90 CAPSULE in 1 BOTTLE, PLASTIC (71610-692-60)Marketed from Mar 10, 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 081297
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Tracheobronchial Stretch Receptor Activity (Physiologic effect)
- Identifiers
- Product ID 71610-692_48b92534-e189-4b18-906f-8a4abcb776a4SPL ID 48b92534-e189-4b18-906f-8a4abcb776a4SPL set ID 3bd33aec-9a30-4581-bd28-6cfb67772cefRxCUI 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
N471610069230followed by a unit qualifier and the quantityPackage 71610-0692-30. 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 is indicated for the symptomatic relief of cough.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 081297
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 200 mg/1 | CapsuleOral | Proficient Rx LP | 71205-605 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Coupler LLC | 67046-1484 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-5105 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-5156 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Proficient Rx LP | 71205-067 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1880 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1927 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 60429-914 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 60429-927 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Bionpharma Inc. | 69452-143 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Bionpharma Inc. | 69452-144 |