Minocycline Hydrochloride
- Product NDC
- 53002-2880
- 11-digit product format
- 530022880
- Labeler code
- 53002
- Product ID
- 53002-2880_67af577e-bca7-4d7c-b218-70d235839c8b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Minocycline Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA063181
- Marketing category
- ANDA
- Marketing start
- 1992-02-01
- Marketing end
- 0000-00-00
- Substance
- MINOCYCLINE HYDROCHLORIDE
- Active strength
- 50 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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d9c90ddb-dcc8-42af-a94b-505e4488bdc7 | Product name | 1 | 20250623 |
| 9e423e97-a6d9-7bb0-0dcb-343af7c0ff92 | Product name | 2 | 20230322 |
| 472a6924-c7ed-850b-32ce-a510e887fbf9 | Product name | 4 | 20230207 |
| f1239550-2d2e-44c3-aec7-14fd9b4ab55d | Product name | 1 | 20201103 |
| 7a57513a-a145-4b95-9165-1e0ef21d6017 | Product name | 1 | 20200326 |
| 70555e58-6951-4421-9354-f80c6ce0d92c | Product name | 7 | 20200204 |
| 23de08d7-aa4e-ec8b-ce6d-2124a855e4ef | Product name | 5 | 20180605 |
| 76736e48-254d-4a39-993d-206efbdaad1d | Product name | 1 | 20170717 |
| 0c498039-5512-d9d7-e6b6-833de47219ff | Product name | 2 | 20151106 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53002-2880-6 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-e824-f424-e053-dadaa90a57ce | Minocycline Hydrochloride Capsules, USP Rx only |
| 53002-2880-6 | 2023-06-08 | C162847 | 48780-1 | 9d75b9d0-e824-f424-e053-dadaa90a57ce | Minocycline Hydrochloride Capsules, USP Rx only |
| 53002-2880-6 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-e824-f424-e053-dadaa90a57ce | Minocycline Hydrochloride Capsules, USP Rx only |
| 53002-2880-6 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-e824-f424-e053-dadaa90a57ce | Minocycline Hydrochloride Capsules, USP Rx only |
| 53002-2880-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e824-f424-e053-dadaa90a57ce | Minocycline Hydrochloride Capsules, USP Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-2880-6 | Minocycline Hydrochloride | 60 in 1 BOTTLE | CAPSULE | 60 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-2880 | MINOCYCLINE HYDROCHLORIDE CAPSULE [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20230609_f4b434e3-31c2-4e5b-8dff-9bc4636d9790.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197985 | minocycline HCl 50 MG Oral Capsule | PSN | f4b434e3-31c2-4e5b-8dff-9bc4636d9790 | 5 |
| 197985 | minocycline 50 MG Oral Capsule | SCD | f4b434e3-31c2-4e5b-8dff-9bc4636d9790 | 5 |
| 197985 | minocycline (as minocycline HCl) 50 MG Oral Capsule | SY | f4b434e3-31c2-4e5b-8dff-9bc4636d9790 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-2880-6 | 53002288006 | 60 CAPSULE in 1 BOTTLE (53002-2880-6) | 60 capsule | 2018-10-01 | 0000-00-00 | No | No | Current |