Prescription drug · ANDA
Benzonatate NDC 68084-214
Benzonatate 100 mg/1 · Capsule · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-214-01 | 68084021401 | 10 BLISTER PACK in 1 CARTON (68084-214-01) / 10 CAPSULE in 1 BLISTER PACK (68084-214-11)Marketed from May 26, 2021 |
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
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040597
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Tracheobronchial Stretch Receptor Activity (Physiologic effect)
- Identifiers
- Product ID 68084-214_235a2641-ce68-1f9c-e063-6394a90ac8a7SPL ID 235a2641-ce68-1f9c-e063-6394a90ac8a7SPL set ID 9a71725a-64b6-4800-a79c-aa4b2d74d44fRxCUI 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
N468084021401followed by a unit qualifier and the quantityPackage 68084-0214-01. 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 are indicated for the symptomatic relief of cough.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040597
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 | Capsule, Liquid filledOral | Major Pharmaceuticals | 0904-6564 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6387 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 65841-843 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | DIRECT RX | 61919-400 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6850 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Proficient Rx LP | 63187-799 |
| Benzonatate | Benzonatate 200 mg/1 | Capsule, Liquid filledOral | Zydus Pharmaceuticals USA Inc. | 68382-091 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Redpharm Drug | 67296-2153 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0091 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2790 |
| Benzonatate | Benzonatate 100 mg/1 | Capsule, Liquid filledOral | Zydus Pharmaceuticals USA Inc. | 68382-247 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8405 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 65841-614 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2590 |