Benzonatate
- Product NDC
- 72865-117
- 11-digit product format
- 728650117
- Labeler code
- 72865
- Product ID
- 72865-117_f3f6fdbf-2aa1-4ce3-b3aa-abab79b546c1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- XLCare Pharmaceuticals, Inc.
- Application
- ANDA211518
- Marketing category
- ANDA
- Marketing start
- 2020-02-17
- 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
- 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5P4DHS6ENR |
| Rxcui | 197397, 283417, 903291 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72865-117-01 | Benzonatate | 100 in 1 BOTTLE | CAPSULE | 100 | | 3 |
| 72865-117-05 | Benzonatate | 500 in 1 BOTTLE | CAPSULE | 500 | | 3 |
| 72865-117-30 | Benzonatate | 30 in 1 BOTTLE | CAPSULE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72865-117 | BENZONATATE CAPSULE [XLCARE PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 3 package rows | 20220128_e33afd96-5ad3-4033-b067-981ac2ed2bea.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 |
|---|
| 72865-117-01 | 72865011701 | 100 CAPSULE in 1 BOTTLE (72865-117-01) | 100 capsule | 2020-02-17 | 0000-00-00 | No | No | Current |
| 72865-117-05 | 72865011705 | 500 CAPSULE in 1 BOTTLE (72865-117-05) | 500 capsule | 2020-02-17 | 0000-00-00 | No | No | Current |
| 72865-117-30 | 72865011730 | 30 CAPSULE in 1 BOTTLE (72865-117-30) | 30 capsule | 2020-02-17 | 0000-00-00 | No | No | Current |