Minocycline hydrochloride
- Product NDC
- 68382-317
- 11-digit product format
- 683820317
- Labeler code
- 68382
- Product ID
- 68382-317_0c236c6b-5f2a-4b46-a12f-45c47b90b65a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Minocycline hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA063009
- Marketing category
- ANDA
- Marketing start
- 2017-04-03
- Substance
- MINOCYCLINE HYDROCHLORIDE
- Active strength
- 75 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 | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0020414E5U |
| Rxcui | 197984, 197985, 314108 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-317-01 | Minocycline hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-317 | MINOCYCLINE HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20250427_25acb785-6838-4e62-9e86-ddc30b2b759a.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 |
|---|
| 68382-317-01 | 68382031701 | 100 CAPSULE in 1 BOTTLE (68382-317-01) | 100 capsule | 2017-04-03 | 0000-00-00 | No | No | Current |