Prescription drug · ANDA
Benzonatate NDC 67296-1464
Benzonatate 200 mg/1 · Capsule · Oral · RedPharm Drug, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67296-1464-3 | 67296146403 | 30 CAPSULE in 1 BOTTLE (67296-1464-3)Marketed from Dec 10, 2016 | |
| 67296-1464-5 | 67296146405 | 15 CAPSULE in 1 BOTTLE (67296-1464-5)Marketed from Dec 10, 2016 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- RedPharm Drug, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091133
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Tracheobronchial Stretch Receptor Activity (Physiologic effect)
- Identifiers
- Product ID 67296-1464_3252dab4-e2bc-9842-e063-6394a90a3529SPL ID 3252dab4-e2bc-9842-e063-6394a90a3529SPL set ID f3c2acfc-f598-50ab-e053-2a95a90a11e7RxCUI 283417UNII 5P4DHS6ENRUPC 0364380713074, 0364380712060, 0364380712077
- 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
N467296146403followed by a unit qualifier and the quantityPackage 67296-1464-03. 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 USP are indicated for the symptomatic relief of cough.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091133
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 | AvKARE | 42291-091 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | AvKARE | 42291-092 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8403 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-712 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Strides Pharma Science Limited | 64380-713 |