Benzonatate
- Product NDC
- 51655-762
- 11-digit product format
- 516550762
- Labeler code
- 51655
- Product ID
- 51655-762_4951a381-95f0-cd50-e063-6294a90a916e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA206948
- Marketing category
- ANDA
- Marketing start
- 2021-07-16
- 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 | 283417 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-762-20 | Benzonatate | 20 in 1 BOTTLE, PLASTIC | CAPSULE | 20 | | 2 |
| 51655-762-52 | Benzonatate | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-762 | BENZONATATE CAPSULE [NORTHWIND PHARMACEUTICALS] | 1 | Current NDC, 2 package rows | 20230221_da6cead3-2859-df03-e053-2a95a90a010b.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 |
|---|
| 51655-762-20 | 51655076220 | 20 CAPSULE in 1 BOTTLE, PLASTIC (51655-762-20) | 20 capsule | 2021-07-16 | No | No | Current |
| 51655-762-52 | 51655076252 | 30 CAPSULE in 1 BOTTLE, PLASTIC (51655-762-52) | 30 capsule | 2022-09-29 | No | No | Current |