benzonatate
- Product NDC
- 50436-5995
- 11-digit product format
- 504365995
- Labeler code
- 50436
- Product ID
- 50436-5995_27f420ea-8046-458b-af75-d9869b80e987
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Unit Dose Services
- 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
- No
- Listing certified through
- 2020-12-31
- 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 |
|---|---|---|---|---|---|
| 50436-5995-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2267-a910-e053-dadaa90a0b85 | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 50436-5995-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2267-a910-e053-dadaa90a0b85 | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 50436-5995-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2267-a910-e053-dadaa90a0b85 | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-5995-1 | benzonatate | 20 in 1 BOTTLE | CAPSULE | 20 | 6 | |
| 50436-5995-2 | benzonatate | 30 in 1 BOTTLE | CAPSULE | 30 | 6 | |
| 50436-5995-3 | benzonatate | 15 in 1 BOTTLE | CAPSULE | 15 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-5995-2 | EA - Each | 50436-5995 | 6602bf8e-42d9-490a-8f40-1b9a41c7bc91 | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| benzonatate | ACTIVE INGREDIENT | 5P4DHS6ENR | BENZONATATE CAPSULE [UNIT DOSE SERVICES] | 4 | |
| benzonatate | ACTIVE MOIETY | 5P4DHS6ENR | BENZONATATE CAPSULE [UNIT DOSE SERVICES] | 4 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | BENZONATATE CAPSULE [UNIT DOSE SERVICES] | 4 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | BENZONATATE CAPSULE [UNIT DOSE SERVICES] | 4 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | BENZONATATE CAPSULE [UNIT DOSE SERVICES] | 4 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | BENZONATATE CAPSULE [UNIT DOSE SERVICES] | 4 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | BENZONATATE CAPSULE [UNIT DOSE SERVICES] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | BENZONATATE CAPSULE [UNIT DOSE SERVICES] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BENZONATATE CAPSULE [UNIT DOSE SERVICES] | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-5995 | BENZONATATE CAPSULE [UNIT DOSE SERVICES] | 6 | Legacy NDC, 3 package rows | 20170312_b576efe0-83e3-49ca-b84e-434f67d19fc2.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197397 | benzonatate 100 MG Oral Capsule | PSN | b576efe0-83e3-49ca-b84e-434f67d19fc2 | 6 |
| 197397 | benzonatate 100 MG Oral Capsule | SCD | b576efe0-83e3-49ca-b84e-434f67d19fc2 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-5995-1 | 50436599501 | 20 in 1 BOTTLE | Historical |
| 50436-5995-2 | 50436599502 | 30 in 1 BOTTLE | Historical |
| 50436-5995-3 | 50436599503 | 15 in 1 BOTTLE | Historical |