benzonatate
- Product NDC
- 33261-634
- 11-digit product format
- 332610634
- Labeler code
- 33261
- Product ID
- 33261-634_5e2ff1d2-363a-41a0-b6ac-8ced16c6fb7b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA040749
- Marketing category
- ANDA
- Marketing start
- 2007-07-25
- Marketing end
- 0000-00-00
- 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
- 2019-12-31
- 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 |
|---|---|---|---|---|---|
| 33261-634-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-49ae-f424-e053-dadaa90a57ce | BENZONATATE CAP 100MG 200MG FOR INTERGEL |
| 33261-634-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-49ae-f424-e053-dadaa90a57ce | BENZONATATE CAP 100MG 200MG FOR INTERGEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33261-634-20 | benzonatate | 20 in 1 BOTTLE, PLASTIC | CAPSULE | 20 | 1 | |
| 33261-634-30 | benzonatate | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 33261-634-20 | EA - Each | 33261-634 | a78030f8-320c-4e37-bfe6-e97ad51d9486 | 1 | 2015-10-02 |
| 33261-634-30 | EA - Each | 33261-634 | 5100acbe-b6c0-4231-b004-e3319d2546e0 | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BENZONATATE | ACTIVE INGREDIENT | 5P4DHS6ENR | BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| BENZONATATE | ACTIVE MOIETY | 5P4DHS6ENR | BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197397 | benzonatate 100 MG Oral Capsule | PSN | 3c92ce07-da4e-47f0-ba1a-84f6a758bf17 | 1 |
| 283417 | benzonatate 200 MG Oral Capsule | PSN | 3c92ce07-da4e-47f0-ba1a-84f6a758bf17 | 1 |
| 197397 | benzonatate 100 MG Oral Capsule | SCD | 3c92ce07-da4e-47f0-ba1a-84f6a758bf17 | 1 |
| 283417 | benzonatate 200 MG Oral Capsule | SCD | 3c92ce07-da4e-47f0-ba1a-84f6a758bf17 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 33261-634-20 | 33261063420 | 20 in 1 BOTTLE, PLASTIC | Historical |
| 33261-634-30 | 33261063430 | 30 in 1 BOTTLE, PLASTIC | Historical |