Prescription drug · ANDA
Benzonatate NDC 51224-010
Benzonatate 100 mg/1 · Capsule · Oral · TAGI Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51224-010-50 | 51224001050 | 100 CAPSULE in 1 BOTTLE (51224-010-50)Marketed from Sep 7, 2017 | |
| 51224-010-60 | 51224001060 | 500 CAPSULE in 1 BOTTLE (51224-010-60)Marketed from Sep 7, 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
- TAGI Pharma, 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 51224-010_8c55a83f-07f4-4f96-8b85-b1df90c8e116SPL ID 8c55a83f-07f4-4f96-8b85-b1df90c8e116SPL set ID 89c9ff5e-8929-4e63-bc11-459aa9ce7110RxCUI 197397, 283417UNII 5P4DHS6ENRUPC 0351224010505
- 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
N451224001050followed by a unit qualifier and the quantityPackage 51224-0010-50. 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 | 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 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2475 |
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