benzonatate
- Product NDC
- 53002-5890
- 11-digit product format
- 530025890
- Labeler code
- 53002
- Product ID
- 53002-5890_785edda0-b975-4810-ac0f-b805dc5e4d43
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA040627
- Marketing category
- ANDA
- Marketing start
- 2017-03-22
- 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
- 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 |
|---|
| 53002-5890-1 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-f970-f424-e053-dadaa90a57ce | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-5890-2 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-f970-f424-e053-dadaa90a57ce | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-5890-3 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-f970-f424-e053-dadaa90a57ce | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-5890-5 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-f970-f424-e053-dadaa90a57ce | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-5890-1 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-f970-f424-e053-dadaa90a57ce | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-5890-2 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-f970-f424-e053-dadaa90a57ce | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-5890-3 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-f970-f424-e053-dadaa90a57ce | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-5890-5 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-f970-f424-e053-dadaa90a57ce | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-5890-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-f970-f424-e053-dadaa90a57ce | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-5890-2 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-f970-f424-e053-dadaa90a57ce | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-5890-3 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-f970-f424-e053-dadaa90a57ce | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-5890-5 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-f970-f424-e053-dadaa90a57ce | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-5890-1 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d0-f970-f424-e053-dadaa90a57ce | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-5890-2 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d0-f970-f424-e053-dadaa90a57ce | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-5890-3 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d0-f970-f424-e053-dadaa90a57ce | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-5890-5 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d0-f970-f424-e053-dadaa90a57ce | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-5890-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f970-f424-e053-dadaa90a57ce | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-5890-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f970-f424-e053-dadaa90a57ce | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-5890-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f970-f424-e053-dadaa90a57ce | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-5890-5 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f970-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 |
|---|
| 53002-5890-1 | benzonatate | 10 in 1 BOTTLE | CAPSULE | 10 | | 5 |
| 53002-5890-2 | benzonatate | 20 in 1 BOTTLE | CAPSULE | 20 | | 5 |
| 53002-5890-3 | benzonatate | 30 in 1 BOTTLE | CAPSULE | 30 | | 5 |
| 53002-5890-5 | benzonatate | 15 in 1 BOTTLE | CAPSULE | 15 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-5890 | BENZONATATE CAPSULE [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 4 package rows | 20230609_6d2c40f7-dae1-4a37-9b4b-8c5926c747f6.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 |
|---|
| 53002-5890-1 | 53002589001 | 10 CAPSULE in 1 BOTTLE (53002-5890-1) | 10 capsule | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-5890-2 | 53002589002 | 20 CAPSULE in 1 BOTTLE (53002-5890-2) | 20 capsule | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-5890-3 | 53002589003 | 30 CAPSULE in 1 BOTTLE (53002-5890-3) | 30 capsule | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-5890-5 | 53002589005 | 15 CAPSULE in 1 BOTTLE (53002-5890-5) | 15 capsule | 2018-10-01 | 0000-00-00 | No | No | Current |