Benzonatate
- Product NDC
- 51224-010
- 11-digit product format
- 512240010
- Labeler code
- 51224
- Product ID
- 51224-010_8c55a83f-07f4-4f96-8b85-b1df90c8e116
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- TAGI Pharma, Inc.
- Application
- ANDA202765
- Marketing category
- ANDA
- Marketing start
- 2017-09-07
- 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, 283417 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51224-010-50 | Benzonatate | 100 in 1 BOTTLE | CAPSULE | 100 | | 10 |
| 51224-010-60 | Benzonatate | 500 in 1 BOTTLE | CAPSULE | 500 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BENZONATATE | ACTIVE INGREDIENT | 5P4DHS6ENR | BENZONATATE CAPSULE [TAGI PHARMA, INC.] | 3 | |
| BENZONATATE | ACTIVE MOIETY | 5P4DHS6ENR | BENZONATATE CAPSULE [TAGI PHARMA, INC.] | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | BENZONATATE CAPSULE [TAGI PHARMA, INC.] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | BENZONATATE CAPSULE [TAGI PHARMA, INC.] | 3 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | BENZONATATE CAPSULE [TAGI PHARMA, INC.] | 3 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | BENZONATATE CAPSULE [TAGI PHARMA, INC.] | 3 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | BENZONATATE CAPSULE [TAGI PHARMA, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | BENZONATATE CAPSULE [TAGI PHARMA, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51224-010 | BENZONATATE CAPSULE [TAGI PHARMA, INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20220624_89c9ff5e-8929-4e63-bc11-459aa9ce7110.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 |
|---|
| 51224-010-50 | 51224001050 | 100 CAPSULE in 1 BOTTLE (51224-010-50) | 100 capsule | 2017-09-07 | 0000-00-00 | No | No | Current |
| 51224-010-60 | 51224001060 | 500 CAPSULE in 1 BOTTLE (51224-010-60) | 500 capsule | 2017-09-07 | 0000-00-00 | No | No | Current |