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 100 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-318
Product ID 68382-318_0c236c6b-5f2a-4b46-a12f-45c47b90b65a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA063009
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 68382318
Hyphenated Format 68382-318

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 ANDA063009 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 50 CAPSULE in 1 BOTTLE (68382-318-18)
source: ndc

Packages (1)

68382-318-18 50 CAPSULE in 1 BOTTLE (68382-318-18)

Ingredients (1)

minocycline hydrochloride (100 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": "50 CAPSULE in 1 BOTTLE (68382-318-18)", "package_ndc": "68382-318-18", "marketing_start_date": "20170403"}], "brand_name": "Minocycline hydrochloride", "product_id": "68382-318_0c236c6b-5f2a-4b46-a12f-45c47b90b65a", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Prothrombin Activity [PE]", "Tetracycline-class Drug [EPC]", "Tetracyclines [CS]"], "product_ndc": "68382-318", "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": "100 mg/1"}], "application_number": "ANDA063009", "marketing_category": "ANDA", "marketing_start_date": "20170403", "listing_expiration_date": "20261231"}