Benzonatate
- Product NDC
- 0615-8403
- 11-digit product format
- 006158403
- Labeler code
- 0615
- Product ID
- 0615-8403_888d70d8-eda7-4bca-b78c-30fc56231aba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA091133
- Marketing category
- ANDA
- Marketing start
- 2016-12-10
- Marketing end
- 2026-10-31
- Substance
- BENZONATATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Benzonatate
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 |
|---|
| 0615-8403-05 | Benzonatate | 15 in 1 BLISTER PACK | CAPSULE | 15 | | 6 |
| 0615-8403-21 | Benzonatate | 21 in 1 BLISTER PACK | CAPSULE | 21 | | 6 |
| 0615-8403-39 | Benzonatate | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8403 | BENZONATATE CAPSULE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 5 | Current NDC, Legacy NDC, 3 package rows | 20240814_6f5c19ad-d811-4196-a9c3-4f6b89626b83.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 |
|---|
| 0615-8403-05 | 00615840305 | 15 CAPSULE in 1 BLISTER PACK (0615-8403-05) | 15 capsule | 2024-07-03 | 2026-10-31 | No | No | Historical |
| 0615-8403-21 | 00615840321 | 21 CAPSULE in 1 BLISTER PACK (0615-8403-21) | 21 capsule | 2024-02-12 | 2026-10-31 | No | No | Historical |
| 0615-8403-39 | 00615840339 | 30 CAPSULE in 1 BLISTER PACK (0615-8403-39) | 30 capsule | 2021-10-06 | 2026-10-31 | No | No | Current |