benzonatate
- Product NDC
- 21695-191
- 11-digit product format
- 216950191
- Labeler code
- 21695
- Product ID
- 21695-191_15dd2f41-952b-40d2-a9bb-5e1cb8802e5e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA040627
- Marketing category
- ANDA
- Marketing start
- 2007-07-25
- 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 |
|---|---|---|---|---|---|
| 21695-191-10 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4bc6-48b1-e053-8cdaa90a720a | 15dd2f41-952b-40d2-a9bb-5e1cb8802e5e |
| 21695-191-14 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4bc6-48b1-e053-8cdaa90a720a | 15dd2f41-952b-40d2-a9bb-5e1cb8802e5e |
| 21695-191-15 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4bc6-48b1-e053-8cdaa90a720a | 15dd2f41-952b-40d2-a9bb-5e1cb8802e5e |
| 21695-191-20 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4bc6-48b1-e053-8cdaa90a720a | 15dd2f41-952b-40d2-a9bb-5e1cb8802e5e |
| 21695-191-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4bc6-48b1-e053-8cdaa90a720a | 15dd2f41-952b-40d2-a9bb-5e1cb8802e5e |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-191-10 | benzonatate | 10 in 1 BOTTLE | CAPSULE | 10 | 1 | |
| 21695-191-14 | benzonatate | 14 in 1 BOTTLE | CAPSULE | 14 | 1 | |
| 21695-191-15 | benzonatate | 15 in 1 BOTTLE | CAPSULE | 15 | 1 | |
| 21695-191-20 | benzonatate | 20 in 1 BOTTLE | CAPSULE | 20 | 1 | |
| 21695-191-30 | benzonatate | 30 in 1 BOTTLE | CAPSULE | 30 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-191-10 | EA - Each | 21695-191 | c28af98b-1b66-4f4e-af4c-7f22d584df20 | 1 | 2012-07-24 |
| 21695-191-14 | EA - Each | 21695-191 | 41d59113-4e90-4a0e-b0b4-5c5f22898156 | 1 | 2012-07-24 |
| 21695-191-15 | EA - Each | 21695-191 | 6dbe401d-7b6a-4a94-964f-a1a4331c9f7e | 1 | 2012-07-24 |
| 21695-191-20 | EA - Each | 21695-191 | 854aae7e-d2d2-45b6-8d08-4c3f0e6eddc4 | 1 | 2012-07-24 |
| 21695-191-30 | EA - Each | 21695-191 | 5e31dc18-1d82-4fc6-a82a-2ec072944c50 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| benzonatate | ACTIVE INGREDIENT | 5P4DHS6ENR | BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| benzonatate | ACTIVE MOIETY | 5P4DHS6ENR | BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | BENZONATATE CAPSULE [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 | 15dd2f41-952b-40d2-a9bb-5e1cb8802e5e | 1 |
| 283417 | benzonatate 200 MG Oral Capsule | PSN | 15dd2f41-952b-40d2-a9bb-5e1cb8802e5e | 1 |
| 197397 | benzonatate 100 MG Oral Capsule | SCD | 15dd2f41-952b-40d2-a9bb-5e1cb8802e5e | 1 |
| 283417 | benzonatate 200 MG Oral Capsule | SCD | 15dd2f41-952b-40d2-a9bb-5e1cb8802e5e | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-191-10 | 21695019110 | 10 in 1 BOTTLE | Historical |
| 21695-191-14 | 21695019114 | 14 in 1 BOTTLE | Historical |
| 21695-191-15 | 21695019115 | 15 in 1 BOTTLE | Historical |
| 21695-191-20 | 21695019120 | 20 in 1 BOTTLE | Historical |
| 21695-191-30 | 21695019130 | 30 in 1 BOTTLE | Historical |