benzonatate
- Product NDC
- 53002-0412
- 11-digit product format
- 530020412
- Labeler code
- 53002
- Product ID
- 53002-0412_daa38471-991b-43e3-8a25-c041105261e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA040749
- Marketing category
- ANDA
- Marketing start
- 2017-03-22
- 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 |
|---|
| 53002-0412-1 | 2025-01-30 | C162847 | 48780-1 | f386c649-d2ec-0266-e053-dadaa90a7c1a | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-0412-2 | 2025-01-30 | C162847 | 48780-1 | f386c649-d2ec-0266-e053-dadaa90a7c1a | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-0412-3 | 2025-01-30 | C162847 | 48780-1 | f386c649-d2ec-0266-e053-dadaa90a7c1a | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-0412-4 | 2025-01-30 | C162847 | 48780-1 | f386c649-d2ec-0266-e053-dadaa90a7c1a | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-0412-1 | 2023-06-07 | C162847 | 48780-1 | f386c649-d2ec-0266-e053-dadaa90a7c1a | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-0412-2 | 2023-06-07 | C162847 | 48780-1 | f386c649-d2ec-0266-e053-dadaa90a7c1a | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-0412-3 | 2023-06-07 | C162847 | 48780-1 | f386c649-d2ec-0266-e053-dadaa90a7c1a | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-0412-4 | 2023-06-07 | C162847 | 48780-1 | f386c649-d2ec-0266-e053-dadaa90a7c1a | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-0412-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-d2ec-0266-e053-dadaa90a7c1a | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-0412-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-d2ec-0266-e053-dadaa90a7c1a | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-0412-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-d2ec-0266-e053-dadaa90a7c1a | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 53002-0412-4 | 2023-01-30 | C162847 | 48780-1 | f386c649-d2ec-0266-e053-dadaa90a7c1a | 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 |
|---|
| 53002-0412-1 | benzonatate | 10 in 1 BOTTLE | CAPSULE | 10 | | 6 |
| 53002-0412-2 | benzonatate | 15 in 1 BOTTLE | CAPSULE | 15 | | 6 |
| 53002-0412-3 | benzonatate | 20 in 1 BOTTLE | CAPSULE | 20 | | 6 |
| 53002-0412-4 | benzonatate | 30 in 1 BOTTLE | CAPSULE | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-0412 | BENZONATATE CAPSULE [RPK PHARMACEUTICALS, INC.] | 6 | Legacy NDC, 4 package rows | 20230609_9e1a2e84-c27a-4cb6-addb-cbe5d4b7d70e.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 |
|---|
| 53002-0412-1 | 53002041201 | 10 CAPSULE in 1 BOTTLE (53002-0412-1) | 10 capsule | 2019-01-01 | 0000-00-00 | No | No | Current |
| 53002-0412-2 | 53002041202 | 15 CAPSULE in 1 BOTTLE (53002-0412-2) | 15 capsule | 2019-01-01 | 0000-00-00 | No | No | Current |
| 53002-0412-3 | 53002041203 | 20 CAPSULE in 1 BOTTLE (53002-0412-3) | 20 capsule | 2019-01-01 | 0000-00-00 | No | No | Current |
| 53002-0412-4 | 53002041204 | 30 CAPSULE in 1 BOTTLE (53002-0412-4) | 30 capsule | 2019-01-01 | 0000-00-00 | No | No | Current |