minocycline hydrochloride

Generic: minocycline hydrochloride

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name minocycline hydrochloride
Generic Name minocycline hydrochloride
Labeler zydus pharmaceuticals usa inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

minocycline hydrochloride 50 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-316
Product ID 68382-316_0c236c6b-5f2a-4b46-a12f-45c47b90b65a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA063011
Listing Expiration 2026-12-31
Marketing Start 2017-04-03

Pharmacologic Class

Classes
decreased prothrombin activity [pe] tetracycline-class drug [epc] tetracyclines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382316
Hyphenated Format 68382-316

Supplemental Identifiers

RxCUI
197984 197985 314108
UNII
0020414E5U

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name minocycline hydrochloride (source: ndc)
Generic Name minocycline hydrochloride (source: ndc)
Application Number ANDA063011 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (68382-316-01)
source: ndc

Packages (1)

68382-316-01 100 CAPSULE in 1 BOTTLE (68382-316-01)

Ingredients (1)

minocycline hydrochloride (50 mg/1)

Linked Drug Pages (1)

Minocycline hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0c236c6b-5f2a-4b46-a12f-45c47b90b65a", "openfda": {"unii": ["0020414E5U"], "rxcui": ["197984", "197985", "314108"], "spl_set_id": ["25acb785-6838-4e62-9e86-ddc30b2b759a"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68382-316-01)", "package_ndc": "68382-316-01", "marketing_start_date": "20170403"}], "brand_name": "Minocycline hydrochloride", "product_id": "68382-316_0c236c6b-5f2a-4b46-a12f-45c47b90b65a", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Prothrombin Activity [PE]", "Tetracycline-class Drug [EPC]", "Tetracyclines [CS]"], "product_ndc": "68382-316", "generic_name": "Minocycline hydrochloride", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Minocycline hydrochloride", "active_ingredients": [{"name": "MINOCYCLINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA063011", "marketing_category": "ANDA", "marketing_start_date": "20170403", "listing_expiration_date": "20261231"}