BENZONATATE
- Product NDC
- 67877-575
- 11-digit product format
- 678770575
- Labeler code
- 67877
- Product ID
- 67877-575_c4c367db-c1ef-4b68-b373-987b36e51f50
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BENZONATATE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA040627
- Marketing category
- ANDA
- Marketing start
- 2017-03-22
- 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
- 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5P4DHS6ENR |
| Rxcui | 197397, 283417 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 67877-575-01 | 2024-11-23 | C162847 | 48780-1 | c7ccaba7-27d8-fd44-e053-dadaa90aa01b | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 67877-575-05 | 2024-11-23 | C162847 | 48780-1 | c7ccaba7-27d8-fd44-e053-dadaa90aa01b | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 67877-575-01 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-27d8-fd44-e053-dadaa90aa01b | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 67877-575-05 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-27d8-fd44-e053-dadaa90aa01b | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67877-575-01 | BENZONATATE | 100 in 1 BOTTLE | CAPSULE | 100 | | 7 |
| 67877-575-05 | BENZONATATE | 500 in 1 BOTTLE | CAPSULE | 500 | | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-575 | BENZONATATE CAPSULE [ASCEND LABORATORIES, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241123_54374c04-63b9-49fa-b6a2-4a711e322d8e.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 |
|---|
| 67877-575-01 | 67877057501 | 100 CAPSULE in 1 BOTTLE (67877-575-01) | 100 capsule | 2017-03-22 | 0000-00-00 | No | No | Current |
| 67877-575-05 | 67877057505 | 500 CAPSULE in 1 BOTTLE (67877-575-05) | 500 capsule | 2017-03-22 | 0000-00-00 | No | No | Current |