Prescription drug · ANDA
Benzonatate NDC 0904-7153
Benzonatate 100 mg/1 · Capsule · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7153-61 | 00904715361 | 100 BLISTER PACK in 1 CARTON (0904-7153-61) / 1 CAPSULE in 1 BLISTER PACKMarketed from Dec 21, 2018 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206948
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Tracheobronchial Stretch Receptor Activity (Physiologic effect)
- Identifiers
- Product ID 0904-7153_97c90be4-2fea-43b1-b177-5e42e5c650b8SPL ID 97c90be4-2fea-43b1-b177-5e42e5c650b8SPL set ID 324f65ae-09d1-4bd6-9d2b-593035201ecdRxCUI 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
N400904715361followed by a unit qualifier and the quantityPackage 00904-7153-61. 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 206948
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 | QPharma Inc | 42708-171 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-3372 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-5083 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-700 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Proficient Rx LP | 71205-632 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5986 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Epic Pharma LLC | 42806-714 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Epic Pharma LLC | 42806-715 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-5223 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | DIRECT RX | 72189-194 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | DIRECT RX | 72189-192 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Sportpharm LLC | 85766-089 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1544 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Sportpharm LLC | 85766-090 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1553 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc | 68788-7607 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2491 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-803 |
| Benzonatate | Benzonatate 200 mg/1 | CapsuleOral | Proficient Rx LP | 71205-643 |
| Benzonatate | Benzonatate 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5409 |
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