Benzonatate
- Product NDC
- 69387-119
- 11-digit product format
- 693870119
- Labeler code
- 69387
- Product ID
- 69387-119_e60439e5-5de9-4b39-9617-c2e471da7e56
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Banner Life Sciences LLC.
- Application
- ANDA081297
- Marketing category
- ANDA
- Marketing start
- 2015-06-01
- 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 |
|---|---|---|---|---|---|
| 69387-119-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-288f-f424-e053-dadaa90a57ce | BENZONATATE CAPSULES USP, 100 mg and 200 mg |
| 69387-119-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-288f-f424-e053-dadaa90a57ce | BENZONATATE CAPSULES USP, 100 mg and 200 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69387-119-01 | Benzonatate | 100 in 1 BOTTLE, PLASTIC | CAPSULE | 100 | 2 | |
| 69387-119-05 | Benzonatate | 500 in 1 BOTTLE, PLASTIC | CAPSULE | 500 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69387-119-01 | EA - Each | 69387-119 | c9e51f0f-539f-4d64-9537-e34266ce39f0 | 1 | 2015-09-10 |
| 69387-119-05 | EA - Each | 69387-119 | bbcf4bd0-f3da-40b8-ab51-6cf85d597e9e | 1 | 2015-09-10 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Benzonatate | ACTIVE INGREDIENT | 5P4DHS6ENR | BENZONATATE CAPSULE [BANNER LIFE SCIENCES LLC.] | 2 | |
| Benzonatate | ACTIVE MOIETY | 5P4DHS6ENR | BENZONATATE CAPSULE [BANNER LIFE SCIENCES LLC.] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | BENZONATATE CAPSULE [BANNER LIFE SCIENCES LLC.] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | BENZONATATE CAPSULE [BANNER LIFE SCIENCES LLC.] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | BENZONATATE CAPSULE [BANNER LIFE SCIENCES LLC.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BENZONATATE CAPSULE [BANNER LIFE SCIENCES LLC.] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197397 | benzonatate 100 MG Oral Capsule | PSN | 50497c81-882a-0707-e054-00144ff88e88 | 2 |
| 197397 | benzonatate 100 MG Oral Capsule | PSN | ef556df2-6c68-454e-87d3-8fd918908e4f | 2 |
| 283417 | benzonatate 200 MG Oral Capsule | PSN | ef556df2-6c68-454e-87d3-8fd918908e4f | 2 |
| 197397 | benzonatate 100 MG Oral Capsule | SCD | 50497c81-882a-0707-e054-00144ff88e88 | 2 |
| 197397 | benzonatate 100 MG Oral Capsule | SCD | ef556df2-6c68-454e-87d3-8fd918908e4f | 2 |
| 283417 | benzonatate 200 MG Oral Capsule | SCD | ef556df2-6c68-454e-87d3-8fd918908e4f | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 69387-119-01 | 69387011901 | 100 in 1 BOTTLE, PLASTIC | Historical |
| 69387-119-05 | 69387011905 | 500 in 1 BOTTLE, PLASTIC | Historical |