Prescription drug · ANDA
Benzonatate NDC 68094-901
Benzonatate 200 mg/1 · Capsule · Oral · Precision Dose, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68094-901-50 | 68094090150 | 100 CAPSULE in 1 BOTTLE (68094-901-50)Marketed from Mar 1, 2024 | |
| 68094-901-60 | 68094090160 | 500 CAPSULE in 1 BOTTLE (68094-901-60)Marketed from Mar 1, 2024 |
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 — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Precision Dose, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202765
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Tracheobronchial Stretch Receptor Activity (Physiologic effect)
- Identifiers
- Product ID 68094-901_02b6bfad-6cc9-4e9e-9320-3ba093f5ae8bSPL ID 02b6bfad-6cc9-4e9e-9320-3ba093f5ae8bSPL set ID 978d0c83-bc01-49b2-a08a-61d72ee58ff8RxCUI 197397, 283417UNII 5P4DHS6ENRUPC 0368094901505, 0368094798501
- 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
N468094090150followed by a unit qualifier and the quantityPackage 68094-0901-50. 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 Capsule is indicated for the symptomatic relief of cough.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202765
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 | Rising Pharma Holdings, Inc. | 64980-634 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 64980-635 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4497 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2672 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8661 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Redpharm Drug | 67296-2194 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4558 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | TAGI Pharma, Inc. | 51224-001 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-9189 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | TAGI Pharma, Inc. | 51224-010 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-869 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0031 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Redpharm Drug | 67296-2244 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1560 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1561 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-4969 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-4968 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1968 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2474 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2473 |
Showing 20 of 26.