Benzonatate
- Product NDC
- 62135-440
- 11-digit product format
- 621350440
- Labeler code
- 62135
- Product ID
- 62135-440_f8703b53-c89b-9014-e053-6294a90a4006
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA040682
- Marketing category
- ANDA
- Marketing start
- 2018-05-01
- Substance
- BENZONATATE
- Active strength
- 100 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Benzonatate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZONATATE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5P4DHS6ENR |
| Rxcui | 197397, 283417 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-440-01 | Benzonatate | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
| 62135-440-31 | Benzonatate | 300 in 1 BOTTLE | CAPSULE | 300 | | 2 |
| 62135-440-90 | Benzonatate | 90 in 1 BOTTLE | CAPSULE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-440 | BENZONATATE CAPSULE [CHARTWELL RX, LLC] | 2 | Current NDC, Legacy NDC, 3 package rows | 20230404_8a17033c-1ad3-4c7a-92ee-f55756833986.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62135-440-01 | 62135044001 | 100 CAPSULE in 1 BOTTLE (62135-440-01) | 100 capsule | 2023-03-22 | | No | No | Current |
| 62135-440-31 | 62135044031 | 300 CAPSULE in 1 BOTTLE (62135-440-31) | 300 capsule | 2023-01-05 | 0000-00-00 | No | No | Current |
| 62135-440-90 | 62135044090 | 90 CAPSULE in 1 BOTTLE (62135-440-90) | 90 capsule | 2023-01-05 | 0000-00-00 | No | No | Current |