BENZONATATE
- Product NDC
- 61919-400
- 11-digit product format
- 619190400
- Labeler code
- 61919
- Product ID
- 61919-400_2e5c46d0-92ba-9396-e063-6294a90a1f79
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BENZONATATE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA040597
- Marketing category
- ANDA
- Marketing start
- 2018-03-12
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BENZONATATE
- Listing expiration
- 2026-12-31
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 |
|---|
| 61919-400-20 | BENZONATATE | 20 in 1 BOTTLE | CAPSULE | 20 | | 5 |
| 61919-400-30 | BENZONATATE | 30 in 1 BOTTLE | CAPSULE | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-400 | BENZONATATE CAPSULE [DIRECT RX] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250221_673bf826-a005-7a38-e053-2991aa0a4cb5.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 |
|---|
| 61919-400-20 | 61919040020 | 20 CAPSULE in 1 BOTTLE (61919-400-20) | 20 capsule | 2018-03-12 | 0000-00-00 | No | No | Current |
| 61919-400-30 | 61919040030 | 30 CAPSULE in 1 BOTTLE (61919-400-30) | 30 capsule | 2018-03-12 | | No | No | Current |