minocycline hydrochloride

Generic: minocycline hydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name minocycline hydrochloride
Generic Name minocycline hydrochloride
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

minocycline hydrochloride 65 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-555
Product ID 65862-555_5569f0f6-b36f-4149-aee7-2699fa5ebe53
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202261
Listing Expiration 2026-12-31
Marketing Start 2018-09-28

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 65862555
Hyphenated Format 65862-555

Supplemental Identifiers

RxCUI
629695 629697 629699 858062 858372 1013659 1013662 1013665
UPC
0365862555304
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 ANDA202261 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 65 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-555-30)
  • 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-555-99)
source: ndc

Packages (2)

65862-555-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-555-30) 65862-555-99 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-555-99)

Ingredients (1)

minocycline hydrochloride (65 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": "5569f0f6-b36f-4149-aee7-2699fa5ebe53", "openfda": {"upc": ["0365862555304"], "unii": ["0020414E5U"], "rxcui": ["629695", "629697", "629699", "858062", "858372", "1013659", "1013662", "1013665"], "spl_set_id": ["e7b88a48-12b3-461d-b356-0d7ae4e8fd44"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-555-30)", "package_ndc": "65862-555-30", "marketing_start_date": "20180928"}, {"sample": false, "description": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-555-99)", "package_ndc": "65862-555-99", "marketing_start_date": "20180928"}], "brand_name": "Minocycline Hydrochloride", "product_id": "65862-555_5569f0f6-b36f-4149-aee7-2699fa5ebe53", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Decreased Prothrombin Activity [PE]", "Tetracycline-class Drug [EPC]", "Tetracyclines [CS]"], "product_ndc": "65862-555", "generic_name": "Minocycline Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Minocycline Hydrochloride", "active_ingredients": [{"name": "MINOCYCLINE HYDROCHLORIDE", "strength": "65 mg/1"}], "application_number": "ANDA202261", "marketing_category": "ANDA", "marketing_start_date": "20180928", "listing_expiration_date": "20261231"}