Prescription drug · ANDA
Benzonatate NDC 71335-0091
Benzonatate 100 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0091-0 | 71335009100 | 10 CAPSULE in 1 BOTTLE (71335-0091-0)Marketed from Apr 30, 2019 | |
| 71335-0091-1 | 71335009101 | 30 CAPSULE in 1 BOTTLE (71335-0091-1)Marketed from Apr 30, 2019 | |
| 71335-0091-2 | 71335009102 | 20 CAPSULE in 1 BOTTLE (71335-0091-2)Marketed from Apr 30, 2019 | |
| 71335-0091-3 | 71335009103 | 100 CAPSULE in 1 BOTTLE (71335-0091-3)Marketed from Apr 30, 2019 | |
| 71335-0091-4 | 71335009104 | 15 CAPSULE in 1 BOTTLE (71335-0091-4)Marketed from Apr 30, 2019 | |
| 71335-0091-5 | 71335009105 | 120 CAPSULE in 1 BOTTLE (71335-0091-5)Marketed from Apr 30, 2019 | |
| 71335-0091-6 | 71335009106 | 60 CAPSULE in 1 BOTTLE (71335-0091-6)Marketed from Apr 30, 2019 | |
| 71335-0091-7 | 71335009107 | 90 CAPSULE in 1 BOTTLE (71335-0091-7)Marketed from Apr 30, 2019 | |
| 71335-0091-8 | 71335009108 | 14 CAPSULE in 1 BOTTLE (71335-0091-8)Marketed from Apr 30, 2019 | |
| 71335-0091-9 | 71335009109 | 40 CAPSULE in 1 BOTTLE (71335-0091-9)Marketed from Apr 30, 2019 |
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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- 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 71335-0091_f721a18a-c457-4c4a-98de-2288d21916a7SPL ID f721a18a-c457-4c4a-98de-2288d21916a7SPL set ID 751d9d60-cd6b-4aa1-b68f-61b86c4059adRxCUI 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
N471335009100followed by a unit qualifier and the quantityPackage 71335-0091-00. 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 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 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | American Health Packaging | 68084-214 |
| 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 | Redpharm Drug | 67296-2153 |
| 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 | Bryant Ranch Prepack | 71335-2790 |
| Benzonatate | Benzonatate 100 mg/1 | Capsule, Liquid filledOral | Zydus Pharmaceuticals USA Inc. | 68382-247 |