Benzonatate
- Product NDC
- 71335-2788
- 11-digit product format
- 713352788
- Labeler code
- 71335
- Product ID
- 71335-2788_49aa4f8a-3d21-4a77-88df-c1501194ec9d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA211518
- Marketing category
- ANDA
- Marketing start
- 2019-02-22
- 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 |
|---|
| 71335-2788-1 | Benzonatate | 21 in 1 BOTTLE | CAPSULE | 21 | | 1 |
| 71335-2788-2 | Benzonatate | 100 in 1 BOTTLE | CAPSULE | 100 | | 1 |
| 71335-2788-3 | Benzonatate | 500 in 1 BOTTLE | CAPSULE | 500 | | 1 |
| 71335-2788-4 | Benzonatate | 10 in 1 BOTTLE | CAPSULE | 10 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2788-1 | 71335278801 | 21 CAPSULE in 1 BOTTLE (71335-2788-1) | 21 capsule | 2026-03-11 | No | No | Historical |
| 71335-2788-2 | 71335278802 | 100 CAPSULE in 1 BOTTLE (71335-2788-2) | 100 capsule | 2026-03-11 | No | No | Historical |
| 71335-2788-3 | 71335278803 | 500 CAPSULE in 1 BOTTLE (71335-2788-3) | 500 capsule | 2026-03-11 | No | No | Historical |
| 71335-2788-4 | 71335278804 | 10 CAPSULE in 1 BOTTLE (71335-2788-4) | 10 capsule | 2026-03-11 | No | No | Historical |