Benzonatate
- Product NDC
- 63187-076
- 11-digit product format
- 631870076
- Labeler code
- 63187
- Product ID
- 63187-076_1e43585a-8e75-4a75-a011-56b5f80cb7cd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA040682
- Marketing category
- ANDA
- Marketing start
- 2010-06-04
- 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 |
|---|
| 63187-076-14 | Benzonatate | 14 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 14 | | 5 |
| 63187-076-20 | Benzonatate | 20 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 20 | | 5 |
| 63187-076-30 | Benzonatate | 30 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 30 | | 5 |
| 63187-076-40 | Benzonatate | 40 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 40 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-076 | BENZONATATE CAPSULE, LIQUID FILLED [PROFICIENT RX LP] | 5 | Current NDC, Legacy NDC, 4 package rows | 20210121_19f1e761-69e9-4330-ad3c-1f1180d70cb0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-076-14 | 63187007614 | 14 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-076-14) | 2018-11-01 | 0000-00-00 | No | No | Current |
| 63187-076-20 | 63187007620 | 20 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-076-20) | 2018-11-01 | 0000-00-00 | No | No | Current |
| 63187-076-30 | 63187007630 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-076-30) | 2018-11-01 | 0000-00-00 | No | No | Current |
| 63187-076-40 | 63187007640 | 40 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-076-40) | 2018-11-01 | 0000-00-00 | No | No | Current |