Benzonatate
- Product NDC
- 67046-1484
- 11-digit product format
- 670461484
- Labeler code
- 67046
- Product ID
- 67046-1484_2ce03083-d6c3-8a00-e063-6294a90aba68
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA081297
- Marketing category
- ANDA
- Marketing start
- 2025-01-29
- 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 |
|---|
| 67046-1484-3 | Benzonatate | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67046-1484 | BENZONATATE CAPSULE [COUPLER LLC] | 1 | Current NDC, 1 package rows | 20250130_2ce035ff-42cb-d8ef-e063-6294a90a0c06.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 |
|---|
| 67046-1484-3 | 67046148403 | 30 CAPSULE in 1 BLISTER PACK (67046-1484-3) | 30 capsule | 2025-01-29 | No | No | Historical |