Benzonatate
- Product NDC
- 42254-078
- 11-digit product format
- 422540078
- Labeler code
- 42254
- Product ID
- 42254-078_ce85fa92-783e-4f71-b7ae-bc0eb0410e13
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA040682
- Marketing category
- ANDA
- Marketing start
- 2010-01-13
- Marketing end
- 0000-00-00
- Substance
- BENZONATATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dc429dc2-e942-6686-8d72-b63c57e806aa | Product name | 5 | 20190416 |
| d45c2ed6-126c-dd22-afd2-e29a2ecf77b9 | Product name | 3 | 20190215 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42254-078-20 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3de8-c013-e053-90daa90a1393 | Benzonatate Capsules, USP 100 mg and 200 mg |
| 42254-078-30 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3de8-c013-e053-90daa90a1393 | Benzonatate Capsules, USP 100 mg and 200 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42254-078-20 | Benzonatate | 20 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 20 | 1 | |
| 42254-078-30 | Benzonatate | 30 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 30 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42254-078-20 | EA - Each | 42254-078 | 66e30459-06f6-4f2e-97e1-534e7d4257f5 | 1 | 2012-07-24 |
| 42254-078-30 | EA - Each | 42254-078 | b17a0ceb-b45f-4da5-9357-ee4ab5858ba4 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BENZONATATE | ACTIVE INGREDIENT | 5P4DHS6ENR | BENZONATATE CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP] | 1 | |
| BENZONATATE | ACTIVE MOIETY | 5P4DHS6ENR | BENZONATATE CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | BENZONATATE CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | BENZONATATE CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | BENZONATATE CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP] | 1 | |
| METHYLPARABEN SODIUM | INACTIVE INGREDIENT | CR6K9C2NHK | BENZONATATE CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP] | 1 | |
| PROPYLPARABEN SODIUM | INACTIVE INGREDIENT | 625NNB0G9N | BENZONATATE CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197397 | benzonatate 100 MG Oral Capsule | PSN | ce85fa92-783e-4f71-b7ae-bc0eb0410e13 | 1 |
| 197397 | benzonatate 100 MG Oral Capsule | SCD | ce85fa92-783e-4f71-b7ae-bc0eb0410e13 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 42254-078-20 | 42254007820 | 20 in 1 BOTTLE | Historical |
| 42254-078-30 | 42254007830 | 30 in 1 BOTTLE | Historical |