BENZONATATE
- Product NDC
- 51655-776
- 11-digit product format
- 516550776
- Labeler code
- 51655
- Product ID
- 51655-776_4ba7befd-4844-5d35-e063-6294a90a1a60
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BENZONATATE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA040627
- Marketing category
- ANDA
- Marketing start
- 2021-04-07
- 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 |
|---|
| 51655-776-52 | BENZONATATE | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 5 |
| 51655-776-54 | BENZONATATE | 15 in 1 BOTTLE, PLASTIC | CAPSULE | 15 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-776 | BENZONATATE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC] | 3 | Current NDC, 2 package rows | 20250101_da807eb3-349e-61b9-e053-2995a90a0e21.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 |
|---|
| 51655-776-52 | 51655077652 | 30 CAPSULE in 1 BOTTLE, PLASTIC (51655-776-52) | 30 capsule | 2021-07-09 | No | No | Current |
| 51655-776-54 | 51655077654 | 15 CAPSULE in 1 BOTTLE, PLASTIC (51655-776-54) | 15 capsule | 2021-04-07 | No | No | Current |