Benzonatate
- Product NDC
- 53002-0411
- 11-digit product format
- 530020411
- Labeler code
- 53002
- Product ID
- 53002-0411_33949016-1f77-4798-9b19-056cd249e6d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA081297
- Marketing category
- ANDA
- Marketing start
- 2016-08-15
- 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
- 2021-12-31
- 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 |
|---|
| 53002-0411-1 | 2025-01-30 | C162847 | 48780-1 | 9d75b9cf-ebc1-f424-e053-dadaa90a57ce | BENZONATATE CAPSULES USP, 100 mg and 200 mg |
| 53002-0411-2 | 2025-01-30 | C162847 | 48780-1 | 9d75b9cf-ebc1-f424-e053-dadaa90a57ce | BENZONATATE CAPSULES USP, 100 mg and 200 mg |
| 53002-0411-3 | 2025-01-30 | C162847 | 48780-1 | 9d75b9cf-ebc1-f424-e053-dadaa90a57ce | BENZONATATE CAPSULES USP, 100 mg and 200 mg |
| 53002-0411-4 | 2025-01-30 | C162847 | 48780-1 | 9d75b9cf-ebc1-f424-e053-dadaa90a57ce | BENZONATATE CAPSULES USP, 100 mg and 200 mg |
| 53002-0411-1 | 2023-06-08 | C162847 | 48780-1 | 9d75b9cf-ebc1-f424-e053-dadaa90a57ce | BENZONATATE CAPSULES USP, 100 mg and 200 mg |
| 53002-0411-2 | 2023-06-08 | C162847 | 48780-1 | 9d75b9cf-ebc1-f424-e053-dadaa90a57ce | BENZONATATE CAPSULES USP, 100 mg and 200 mg |
| 53002-0411-3 | 2023-06-08 | C162847 | 48780-1 | 9d75b9cf-ebc1-f424-e053-dadaa90a57ce | BENZONATATE CAPSULES USP, 100 mg and 200 mg |
| 53002-0411-4 | 2023-06-08 | C162847 | 48780-1 | 9d75b9cf-ebc1-f424-e053-dadaa90a57ce | BENZONATATE CAPSULES USP, 100 mg and 200 mg |
| 53002-0411-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9cf-ebc1-f424-e053-dadaa90a57ce | BENZONATATE CAPSULES USP, 100 mg and 200 mg |
| 53002-0411-2 | 2023-01-30 | C162847 | 48780-1 | 9d75b9cf-ebc1-f424-e053-dadaa90a57ce | BENZONATATE CAPSULES USP, 100 mg and 200 mg |
| 53002-0411-3 | 2023-01-30 | C162847 | 48780-1 | 9d75b9cf-ebc1-f424-e053-dadaa90a57ce | BENZONATATE CAPSULES USP, 100 mg and 200 mg |
| 53002-0411-4 | 2023-01-30 | C162847 | 48780-1 | 9d75b9cf-ebc1-f424-e053-dadaa90a57ce | BENZONATATE CAPSULES USP, 100 mg and 200 mg |
| 53002-0411-1 | 2020-12-15 | C162847 | 48780-1 | 9d75b9cf-ebc1-f424-e053-dadaa90a57ce | BENZONATATE CAPSULES USP, 100 mg and 200 mg |
| 53002-0411-2 | 2020-12-15 | C162847 | 48780-1 | 9d75b9cf-ebc1-f424-e053-dadaa90a57ce | BENZONATATE CAPSULES USP, 100 mg and 200 mg |
| 53002-0411-3 | 2020-12-15 | C162847 | 48780-1 | 9d75b9cf-ebc1-f424-e053-dadaa90a57ce | BENZONATATE CAPSULES USP, 100 mg and 200 mg |
| 53002-0411-4 | 2020-12-15 | C162847 | 48780-1 | 9d75b9cf-ebc1-f424-e053-dadaa90a57ce | BENZONATATE CAPSULES USP, 100 mg and 200 mg |
| 53002-0411-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-ebc1-f424-e053-dadaa90a57ce | BENZONATATE CAPSULES USP, 100 mg and 200 mg |
| 53002-0411-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-ebc1-f424-e053-dadaa90a57ce | BENZONATATE CAPSULES USP, 100 mg and 200 mg |
| 53002-0411-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-ebc1-f424-e053-dadaa90a57ce | BENZONATATE CAPSULES USP, 100 mg and 200 mg |
| 53002-0411-4 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-ebc1-f424-e053-dadaa90a57ce | BENZONATATE CAPSULES USP, 100 mg and 200 mg |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-0411-1 | Benzonatate | 10 in 1 BOTTLE | CAPSULE | 10 | | 5 |
| 53002-0411-2 | Benzonatate | 15 in 1 BOTTLE | CAPSULE | 15 | | 5 |
| 53002-0411-3 | Benzonatate | 20 in 1 BOTTLE | CAPSULE | 20 | | 5 |
| 53002-0411-4 | Benzonatate | 30 in 1 BOTTLE | CAPSULE | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-0411 | BENZONATATE CAPSULE [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 4 package rows | 20230609_63c4ebf2-37b9-4c90-a082-a24c8373a85a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-0411-1 | 53002041101 | 10 CAPSULE in 1 BOTTLE (53002-0411-1) | 10 capsule | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-0411-2 | 53002041102 | 15 CAPSULE in 1 BOTTLE (53002-0411-2) | 15 capsule | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-0411-3 | 53002041103 | 20 CAPSULE in 1 BOTTLE (53002-0411-3) | 20 capsule | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-0411-4 | 53002041104 | 30 CAPSULE in 1 BOTTLE (53002-0411-4) | 30 capsule | 2017-10-01 | 0000-00-00 | No | No | Current |