Benzonatate
- Product NDC
- 0904-6564
- 11-digit product format
- 009046564
- Labeler code
- 0904
- Product ID
- 0904-6564_919d0ef6-6c0e-4ca1-9252-4297d98fdafd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA040597
- Marketing category
- ANDA
- Marketing start
- 2007-09-04
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Benzonatate
- Listing expiration
- 2027-12-31
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 |
|---|
| 0904-6564-60 | Benzonatate | 100 in 1 BOTTLE | CAPSULE | 100 | | 10 |
| 0904-6564-61 | Benzonatate | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 10 |
| 0904-6564-61 | Benzonatate | 100 in 1 CARTON | CAPSULE | 100 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6564 | BENZONATATE CAPSULE [MAJOR PHARMACEUTICALS, INC.] | 9 | Current NDC, Legacy NDC, 3 package rows | 20250406_2256f7e4-b7e6-433f-941e-bf78ddcd55b2.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 |
|---|
| 0904-6564-60 | 00904656460 | 100 CAPSULE in 1 BOTTLE (0904-6564-60) | 100 capsule | 2007-09-04 | 0000-00-00 | No | No | Current |
| 0904-6564-61 | 00904656461 | 100 BLISTER PACK in 1 CARTON (0904-6564-61) > 1 CAPSULE in 1 BLISTER PACK | 100 blister pack | 2007-09-04 | 0000-00-00 | No | No | Current |