benzonatate
- Product NDC
- 50436-5996
- 11-digit product format
- 504365996
- Labeler code
- 50436
- Product ID
- 50436-5996_dc6172ff-43c6-4d41-8395-8ff9a0fc642d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Unit Dose Services
- 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
- 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 |
|---|---|---|---|---|---|
| 50436-5996-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-36cc-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 |
|---|---|---|---|---|---|---|
| 50436-5996-1 | benzonatate | 30 in 1 BOTTLE | CAPSULE | 30 | 4 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| benzonatate | ACTIVE INGREDIENT | 5P4DHS6ENR | BENZONATATE CAPSULE [UNIT DOSE SERVICES] | 2 | |
| benzonatate | ACTIVE MOIETY | 5P4DHS6ENR | BENZONATATE CAPSULE [UNIT DOSE SERVICES] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | BENZONATATE CAPSULE [UNIT DOSE SERVICES] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | BENZONATATE CAPSULE [UNIT DOSE SERVICES] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | BENZONATATE CAPSULE [UNIT DOSE SERVICES] | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | BENZONATATE CAPSULE [UNIT DOSE SERVICES] | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | BENZONATATE CAPSULE [UNIT DOSE SERVICES] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | BENZONATATE CAPSULE [UNIT DOSE SERVICES] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BENZONATATE CAPSULE [UNIT DOSE SERVICES] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-5996 | BENZONATATE CAPSULE [UNIT DOSE SERVICES] | 4 | Legacy NDC, 1 package rows | 20170312_1e998229-51ef-464d-af9f-80c5ce88b8a7.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 283417 | benzonatate 200 MG Oral Capsule | PSN | 1e998229-51ef-464d-af9f-80c5ce88b8a7 | 4 |
| 283417 | benzonatate 200 MG Oral Capsule | SCD | 1e998229-51ef-464d-af9f-80c5ce88b8a7 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-5996-1 | 50436599601 | 30 in 1 BOTTLE | Historical |