Benzonatate
- Product NDC
- 0904-7153
- 11-digit product format
- 009047153
- Labeler code
- 0904
- Product ID
- 0904-7153_a9e81d1d-28ad-422e-9d41-088638605086
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- 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 |
|---|
| 0904-7153-61 | Benzonatate | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 4 |
| 0904-7153-61 | Benzonatate | 100 in 1 CARTON | CAPSULE | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7153 | BENZONATATE CAPSULE [MAJOR PHARMACEUTICALS] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250210_324f65ae-09d1-4bd6-9d2b-593035201ecd.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 |
|---|
| 0904-7153-61 | 00904715361 | 100 BLISTER PACK in 1 CARTON (0904-7153-61) / 1 CAPSULE in 1 BLISTER PACK | 100 blister pack | 2018-12-21 | 0000-00-00 | No | No | Current |