minocycline hydrochloride
- Product NDC
- 68382-550
- 11-digit product format
- 683820550
- Labeler code
- 68382
- Product ID
- 68382-550_d984bc89-8412-45fd-ba75-e707bc53ae3d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- minocycline hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA203553
- Marketing category
- ANDA
- Marketing start
- 2025-06-12
- Substance
- MINOCYCLINE HYDROCHLORIDE
- Active strength
- 55 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 0020414E5U | MINOCYCLINE HYDROCHLORIDE | 13614-98-7 | MINOCYCLINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68382-550-01 | 68382055001 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-550-01) | | 2025-06-12 | No | No | Historical |
| 68382-550-05 | 68382055005 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-550-05) | | 2025-06-12 | No | No | Historical |
| 68382-550-06 | 68382055006 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-550-06) | | 2025-06-12 | No | No | Historical |
| 68382-550-10 | 68382055010 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-550-10) | | 2025-06-12 | No | No | Historical |
| 68382-550-16 | 68382055016 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-550-16) | | 2025-06-12 | No | No | Historical |
| 68382-550-30 | 68382055030 | 10 BLISTER PACK in 1 CARTON (68382-550-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 10 blister pack | 2025-06-12 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| minocycline hydrochloride | Zydus Pharmaceuticals (USA) Inc. | 2025-06-05 | HUMAN PRESCRIPTION DRUG LABEL | 5 |