Benzonatate
- Product NDC
- 68094-798
- 11-digit product format
- 680940798
- Labeler code
- 68094
- Product ID
- 68094-798_02b6bfad-6cc9-4e9e-9320-3ba093f5ae8b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Precision Dose, Inc.
- Application
- ANDA202765
- Marketing category
- ANDA
- Marketing start
- 2024-03-01
- 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 |
|---|
| 68094-798-50 | Benzonatate | 100 in 1 BOTTLE | CAPSULE | 100 | | 1 |
| 68094-798-60 | Benzonatate | 500 in 1 BOTTLE | CAPSULE | 500 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68094-798 | BENZONATATE CAPSULE [PRECISION DOSE, INC.] | 1 | Current NDC, 2 package rows | 20240301_978d0c83-bc01-49b2-a08a-61d72ee58ff8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68094-798-50 | 68094079850 | 100 CAPSULE in 1 BOTTLE (68094-798-50) | 100 capsule | 2024-03-01 | No | No | Historical |
| 68094-798-60 | 68094079860 | 500 CAPSULE in 1 BOTTLE (68094-798-60) | 500 capsule | 2024-03-01 | No | No | Historical |