Minocycline Hydrochloride
- Product NDC
- 50090-5710
- 11-digit product format
- 500905710
- Labeler code
- 50090
- Product ID
- 50090-5710_c71bfca7-0a94-45eb-b0d6-4a1d01c44232
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Minocycline Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA090867
- Marketing category
- ANDA
- Marketing start
- 2013-05-13
- Substance
- MINOCYCLINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Minocycline Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MINOCYCLINE HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0020414E5U |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-5710-0 | 2023-02-07 | C162847 | 48780-1 | f386c649-c137-0266-e053-dadaa90a7c1a | Minocycline Hydrochloride Capsules, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
| 50090-5710-3 | 2023-02-07 | C162847 | 48780-1 | f386c649-c137-0266-e053-dadaa90a7c1a | Minocycline Hydrochloride Capsules, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
| 50090-5710-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-c137-0266-e053-dadaa90a7c1a | Minocycline Hydrochloride Capsules, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
| 50090-5710-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-c137-0266-e053-dadaa90a7c1a | Minocycline Hydrochloride Capsules, USP Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-5710-0 | 50090571000 | 60 CAPSULE in 1 BOTTLE (50090-5710-0) | 60 capsule | 2021-09-24 | 0000-00-00 | No | No | Current |
| 50090-5710-3 | 50090571003 | 90 CAPSULE in 1 BOTTLE (50090-5710-3) | 90 capsule | 2021-09-24 | 0000-00-00 | No | No | Current |