Minocycline Hydrochloride
- Product NDC
- 53002-2210
- 11-digit product format
- 530022210
- Labeler code
- 53002
- Product ID
- 53002-2210_da36bb4f-82aa-413a-9e94-9b05226e1581
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Minocycline Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA065062
- Marketing category
- ANDA
- Marketing start
- 2015-04-02
- Marketing end
- 0000-00-00
- Substance
- MINOCYCLINE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Tetracycline-class Drug [EPC],Tetracyclines [CS]
- 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 |
|---|
| 53002-2210-3 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d1-2427-f424-e053-dadaa90a57ce | MINOCYCLINE HYDROCHLORIDE CAPSULES, USP Rx only |
| 53002-2210-4 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d1-2427-f424-e053-dadaa90a57ce | MINOCYCLINE HYDROCHLORIDE CAPSULES, USP Rx only |
| 53002-2210-6 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d1-2427-f424-e053-dadaa90a57ce | MINOCYCLINE HYDROCHLORIDE CAPSULES, USP Rx only |
| 53002-2210-3 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d1-2427-f424-e053-dadaa90a57ce | MINOCYCLINE HYDROCHLORIDE CAPSULES, USP Rx only |
| 53002-2210-4 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d1-2427-f424-e053-dadaa90a57ce | MINOCYCLINE HYDROCHLORIDE CAPSULES, USP Rx only |
| 53002-2210-6 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d1-2427-f424-e053-dadaa90a57ce | MINOCYCLINE HYDROCHLORIDE CAPSULES, USP Rx only |
| 53002-2210-3 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d1-2427-f424-e053-dadaa90a57ce | MINOCYCLINE HYDROCHLORIDE CAPSULES, USP Rx only |
| 53002-2210-4 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d1-2427-f424-e053-dadaa90a57ce | MINOCYCLINE HYDROCHLORIDE CAPSULES, USP Rx only |
| 53002-2210-6 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d1-2427-f424-e053-dadaa90a57ce | MINOCYCLINE HYDROCHLORIDE CAPSULES, USP Rx only |
| 53002-2210-3 | 2020-12-16 | C162847 | 48780-1 | 9d75b9d1-2427-f424-e053-dadaa90a57ce | MINOCYCLINE HYDROCHLORIDE CAPSULES, USP Rx only |
| 53002-2210-4 | 2020-12-16 | C162847 | 48780-1 | 9d75b9d1-2427-f424-e053-dadaa90a57ce | MINOCYCLINE HYDROCHLORIDE CAPSULES, USP Rx only |
| 53002-2210-6 | 2020-12-16 | C162847 | 48780-1 | 9d75b9d1-2427-f424-e053-dadaa90a57ce | MINOCYCLINE HYDROCHLORIDE CAPSULES, USP Rx only |
| 53002-2210-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2427-f424-e053-dadaa90a57ce | MINOCYCLINE HYDROCHLORIDE CAPSULES, USP Rx only |
| 53002-2210-4 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2427-f424-e053-dadaa90a57ce | MINOCYCLINE HYDROCHLORIDE CAPSULES, USP Rx only |
| 53002-2210-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2427-f424-e053-dadaa90a57ce | MINOCYCLINE HYDROCHLORIDE CAPSULES, USP Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-2210-3 | Minocycline Hydrochloride | 30 in 1 BOTTLE | CAPSULE | 30 | | 5 |
| 53002-2210-4 | Minocycline Hydrochloride | 14 in 1 BOTTLE | CAPSULE | 14 | | 5 |
| 53002-2210-6 | Minocycline Hydrochloride | 60 in 1 BOTTLE | CAPSULE | 60 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-2210 | MINOCYCLINE HYDROCHLORIDE CAPSULE [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 3 package rows | 20230609_b4f98f74-198c-4745-a2b6-4e588898e79f.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 |
|---|
| 53002-2210-3 | 53002221003 | 30 CAPSULE in 1 BOTTLE (53002-2210-3) | 30 capsule | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-2210-4 | 53002221004 | 14 CAPSULE in 1 BOTTLE (53002-2210-4) | 14 capsule | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-2210-6 | 53002221006 | 60 CAPSULE in 1 BOTTLE (53002-2210-6) | 60 capsule | 2018-10-01 | 0000-00-00 | No | No | Current |