arestin

Generic: minocycline hydrochloride

Labeler: orapharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name arestin
Generic Name minocycline hydrochloride
Labeler orapharma, inc.
Dosage Form POWDER
Routes
ORAL
Active Ingredients

minocycline hydrochloride 1 mg/1

Manufacturer
OraPharma, Inc.

Identifiers & Regulatory

Product NDC 65976-100
Product ID 65976-100_668385ee-9443-4d20-b0ea-655c2526ca96
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050781
Listing Expiration 2026-12-31
Marketing Start 2011-03-21

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 65976100
Hyphenated Format 65976-100

Supplemental Identifiers

RxCUI
351121 351974
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 arestin (source: ndc)
Generic Name minocycline hydrochloride (source: ndc)
Application Number NDA050781 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 1 POWDER in 1 POUCH (65976-100-01)
  • 1 POUCH in 1 BOX (65976-100-12) / 1 TRAY in 1 POUCH / 12 POWDER in 1 TRAY
  • 2 POUCH in 1 BOX (65976-100-24) / 1 TRAY in 1 POUCH / 12 POWDER in 1 TRAY
source: ndc

Packages (3)

65976-100-01 1 POWDER in 1 POUCH (65976-100-01) 65976-100-12 1 POUCH in 1 BOX (65976-100-12) / 1 TRAY in 1 POUCH / 12 POWDER in 1 TRAY 65976-100-24 2 POUCH in 1 BOX (65976-100-24) / 1 TRAY in 1 POUCH / 12 POWDER in 1 TRAY

Ingredients (1)

minocycline hydrochloride (1 mg/1)

Linked Drug Pages (1)

Arestin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "668385ee-9443-4d20-b0ea-655c2526ca96", "openfda": {"unii": ["0020414E5U"], "rxcui": ["351121", "351974"], "spl_set_id": ["8515df41-1936-4f3b-86ba-d2bb2a8441fb"], "manufacturer_name": ["OraPharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POWDER in 1 POUCH (65976-100-01)", "package_ndc": "65976-100-01", "marketing_start_date": "20110321"}, {"sample": false, "description": "1 POUCH in 1 BOX (65976-100-12)  / 1 TRAY in 1 POUCH / 12 POWDER in 1 TRAY", "package_ndc": "65976-100-12", "marketing_start_date": "20110321"}, {"sample": false, "description": "2 POUCH in 1 BOX (65976-100-24)  / 1 TRAY in 1 POUCH / 12 POWDER in 1 TRAY", "package_ndc": "65976-100-24", "marketing_start_date": "20110321"}], "brand_name": "Arestin", "product_id": "65976-100_668385ee-9443-4d20-b0ea-655c2526ca96", "dosage_form": "POWDER", "pharm_class": ["Decreased Prothrombin Activity [PE]", "Tetracycline-class Drug [EPC]", "Tetracyclines [CS]"], "product_ndc": "65976-100", "generic_name": "Minocycline Hydrochloride", "labeler_name": "OraPharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Arestin", "active_ingredients": [{"name": "MINOCYCLINE HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "NDA050781", "marketing_category": "NDA", "marketing_start_date": "20110321", "listing_expiration_date": "20261231"}