Benzonatate
- Product NDC
- 70518-4182
- 11-digit product format
- 705184182
- Labeler code
- 70518
- Product ID
- 70518-4182_4a780b07-920c-3496-e063-6294a90adb22
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA211518
- Marketing category
- ANDA
- Marketing start
- 2024-09-24
- Substance
- BENZONATATE
- Active strength
- 200 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5P4DHS6ENR |
| Rxcui | 283417 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4182-0 | Benzonatate | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | | 5 |
| 70518-4182-1 | Benzonatate | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 5 |
| 70518-4182-2 | Benzonatate | 20 in 1 BOTTLE, PLASTIC | CAPSULE | 20 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4182 | BENZONATATE CAPSULE [REMEDYREPACK INC.] | 2 | Current NDC, 3 package rows | 20250122_9815f3f4-fb46-4796-a0ed-62a9e098286d.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 |
|---|
| 70518-4182-0 | 70518418200 | 30 CAPSULE in 1 BOTTLE, PLASTIC (70518-4182-0) | 30 capsule | 2024-09-24 | No | No | Historical |
| 70518-4182-1 | 70518418201 | 30 CAPSULE in 1 BLISTER PACK (70518-4182-1) | 30 capsule | 2025-01-20 | No | No | Historical |
| 70518-4182-2 | 70518418202 | 20 CAPSULE in 1 BOTTLE, PLASTIC (70518-4182-2) | 20 capsule | 2025-12-23 | No | No | Historical |