Benzonatate
- Product NDC
- 68071-2562
- 11-digit product format
- 680712562
- Labeler code
- 68071
- Product ID
- 68071-2562_235c6dec-d33c-929e-e063-6394a90a57ad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA211518
- Marketing category
- ANDA
- Marketing start
- 2019-02-22
- 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
- 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5P4DHS6ENR |
| Rxcui | 283417 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-2562-2 | Benzonatate | 21 in 1 BOTTLE | CAPSULE | 21 | | 5 |
| 68071-2562-3 | 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 |
|---|
| 68071-2562 | BENZONATATE CAPSULE [NUCARE PHARMACEUTICALS,INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241003_cfd54d90-c15d-0d02-e053-2995a90a8b28.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 |
|---|
| 68071-2562-2 | 68071256202 | 21 CAPSULE in 1 BOTTLE (68071-2562-2) | 21 capsule | 2024-09-30 | | No | No | Current |
| 68071-2562-3 | 68071256203 | 30 CAPSULE in 1 BOTTLE (68071-2562-3) | 30 capsule | 2021-11-02 | 0000-00-00 | No | No | Current |