benzonatate
- Product NDC
- 10544-129
- 11-digit product format
- 105440129
- Labeler code
- 10544
- Product ID
- 10544-129_0ff56761-89ec-5239-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA040749
- Marketing category
- ANDA
- Marketing start
- 2010-11-01
- 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 10544-129-09 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d763-f424-e053-dadaa90a57ce | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 10544-129-15 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d763-f424-e053-dadaa90a57ce | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 10544-129-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d763-f424-e053-dadaa90a57ce | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 10544-129-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d763-f424-e053-dadaa90a57ce | 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 |
|---|
| 10544-129-09 | benzonatate | 9 in 1 BOTTLE | CAPSULE | 9 | | 4 |
| 10544-129-15 | benzonatate | 15 in 1 BOTTLE | CAPSULE | 15 | | 4 |
| 10544-129-20 | benzonatate | 20 in 1 BOTTLE | CAPSULE | 20 | | 4 |
| 10544-129-30 | benzonatate | 30 in 1 BOTTLE | CAPSULE | 30 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BENZONATATE | ACTIVE INGREDIENT | 5P4DHS6ENR | BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.] | 4 | |
| BENZONATATE | ACTIVE MOIETY | 5P4DHS6ENR | BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.] | 4 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.] | 4 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.] | 4 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.] | 4 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.] | 4 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-129 | BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.] | 4 | Legacy NDC, 4 package rows | 20150226_00acfc04-3ad0-487e-87dd-e6e632c05b45.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-129-09 | 10544012909 | 9 in 1 BOTTLE | Historical |
| 10544-129-15 | 10544012915 | 15 in 1 BOTTLE | Historical |
| 10544-129-20 | 10544012920 | 20 in 1 BOTTLE | Historical |
| 10544-129-30 | 10544012930 | 30 in 1 BOTTLE | Historical |