Benzonatate
- Product NDC
- 42291-092
- 11-digit product format
- 422910092
- Labeler code
- 42291
- Product ID
- 42291-092_485b7ac3-8e97-f7a7-e063-6294a90a8138
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA091133
- Marketing category
- ANDA
- Marketing start
- 2023-11-29
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Benzonatate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZONATATE | 200 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 |
|---|
| 42291-092-01 | Benzonatate | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-092 | BENZONATATE CAPSULE [AVKARE] | 1 | Current NDC, 1 package rows | 20231130_0b50405c-d399-edcd-e063-6294a90a89c2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42291-092-01 | 42291009201 | 100 CAPSULE in 1 BOTTLE (42291-092-01) | 100 capsule | 2023-11-29 | No | No | Current |