Benzonatate
- Product NDC
- 51655-754
- 11-digit product format
- 516550754
- Labeler code
- 51655
- Product ID
- 51655-754_49516954-2f3a-7b4a-e063-6394a90a3fa4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA206948
- Marketing category
- ANDA
- Marketing start
- 2021-07-15
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-754-20 | Benzonatate | 20 in 1 BOTTLE, PLASTIC | CAPSULE | 20 | | 4 |
| 51655-754-21 | Benzonatate | 21 in 1 BOTTLE, PLASTIC | CAPSULE | 21 | | 4 |
| 51655-754-52 | Benzonatate | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 4 |
| 51655-754-54 | Benzonatate | 15 in 1 BOTTLE, PLASTIC | CAPSULE | 15 | | 4 |
| 51655-754-85 | Benzonatate | 9 in 1 BOTTLE, PLASTIC | CAPSULE | 9 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-754 | BENZONATATE CAPSULE [NORTHWIND PHARMACEUTICALS] | 3 | Current NDC, 5 package rows | 20240110_da6bcd14-2294-e7df-e053-2995a90a4526.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 |
|---|
| 51655-754-20 | 51655075420 | 20 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-20) | 20 capsule | 2021-07-15 | No | No | Current |
| 51655-754-21 | 51655075421 | 21 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-21) | 21 capsule | 2023-05-31 | No | No | Current |
| 51655-754-52 | 51655075452 | 30 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-52) | 30 capsule | 2022-10-05 | No | No | Current |
| 51655-754-54 | 51655075454 | 15 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-54) | 15 capsule | 2022-11-30 | No | No | Current |
| 51655-754-85 | 51655075485 | 9 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-85) | 9 capsule | 2023-12-21 | No | No | Current |