Benzonatate
- Product NDC
- 71335-2590
- 11-digit product format
- 713352590
- Labeler code
- 71335
- Product ID
- 71335-2590_7ed224eb-c573-4dea-a156-3f9b4e536a0f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA040597
- Marketing category
- ANDA
- Marketing start
- 2007-04-09
- Substance
- BENZONATATE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71335-2590_7ed224eb-c573-4dea-a156-3f9b4e536a0f
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Benzonatate
- Generic name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing start
- 2007-04-09
- Marketing category
- ANDA
- Application number
- ANDA040597
- Pharmacologic classes
- Decreased Tracheobronchial Stretch Receptor Activity [PE]; Non-narcotic Antitussive [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| BENZONATATE | 200 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 5P4DHS6ENR |
| Rxcui | 283417 |
| Spl Set Id | 995ebc53-4e13-4c1d-b301-71ac83c6def8 |
| Manufacturer Name | Bryant Ranch Prepack |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 5P4DHS6ENR | BENZONATATE | 104-31-4 | BENZONATATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2590-0 | 71335259000 | 6 CAPSULE in 1 BOTTLE (71335-2590-0) | 6 capsule | 2025-06-04 | No | No | Current |
| 71335-2590-1 | 71335259001 | 30 CAPSULE in 1 BOTTLE (71335-2590-1) | 30 capsule | 2025-06-04 | No | No | Current |
| 71335-2590-2 | 71335259002 | 100 CAPSULE in 1 BOTTLE (71335-2590-2) | 100 capsule | 2025-06-04 | No | No | Current |
| 71335-2590-3 | 71335259003 | 45 CAPSULE in 1 BOTTLE (71335-2590-3) | 45 capsule | 2025-06-04 | No | No | Current |
| 71335-2590-4 | 71335259004 | 20 CAPSULE in 1 BOTTLE (71335-2590-4) | 20 capsule | 2025-06-04 | No | No | Current |
| 71335-2590-5 | 71335259005 | 15 CAPSULE in 1 BOTTLE (71335-2590-5) | 15 capsule | 2025-06-04 | No | No | Current |
| 71335-2590-6 | 71335259006 | 21 CAPSULE in 1 BOTTLE (71335-2590-6) | 21 capsule | 2025-06-04 | No | No | Current |
| 71335-2590-7 | 71335259007 | 60 CAPSULE in 1 BOTTLE (71335-2590-7) | 60 capsule | 2025-06-04 | No | No | Current |
| 71335-2590-8 | 71335259008 | 50 CAPSULE in 1 BOTTLE (71335-2590-8) | 50 capsule | 2025-06-04 | No | No | Current |
| 71335-2590-9 | 71335259009 | 90 CAPSULE in 1 BOTTLE (71335-2590-9) | 90 capsule | 2025-06-04 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Benzonatate Capsules, USP | Bryant Ranch Prepack | 2025-06-04 | HUMAN PRESCRIPTION DRUG LABEL | 1 |