Benzonatate
- Product NDC
- 68071-5223
- 11-digit product format
- 680715223
- Labeler code
- 68071
- Product ID
- 68071-5223_1b59145d-faea-ead2-e063-6394a90a53dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA206948
- Marketing category
- ANDA
- Marketing start
- 2018-12-21
- 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 |
|---|
| 68071-5223-4 | Benzonatate | 4 in 1 BOTTLE | CAPSULE | 4 | | 3 |
| 68071-5223-6 | Benzonatate | 6 in 1 BOTTLE | CAPSULE | 6 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-5223 | BENZONATATE CAPSULE [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240622_a2167f23-95bf-baa2-e053-2a95a90a7bbd.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 |
|---|
| 68071-5223-4 | 68071522304 | 4 CAPSULE in 1 BOTTLE (68071-5223-4) | 4 capsule | 2020-03-30 | 0000-00-00 | No | No | Current |
| 68071-5223-6 | 68071522306 | 6 CAPSULE in 1 BOTTLE (68071-5223-6) | 6 capsule | 2020-03-30 | 0000-00-00 | No | No | Current |