minocycline hydrochloride

Generic: minocycline hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name minocycline hydrochloride
Generic Name minocycline hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

minocycline hydrochloride 105 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-528
Product ID 72789-528_3e794c61-ef94-8751-e063-6294a90aafc4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204453
Listing Expiration 2026-12-31
Marketing Start 2016-09-30

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 72789528
Hyphenated Format 72789-528

Supplemental Identifiers

RxCUI
629695 629697 858062 858372 1013659 1013662 1013665
UNII
0020414E5U

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 ANDA204453 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 105 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-528-30)
source: ndc

Packages (1)

72789-528-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-528-30)

Ingredients (1)

minocycline hydrochloride (105 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": "3e794c61-ef94-8751-e063-6294a90aafc4", "openfda": {"unii": ["0020414E5U"], "rxcui": ["629695", "629697", "858062", "858372", "1013659", "1013662", "1013665"], "spl_set_id": ["3e796794-b731-61d6-e063-6394a90aa9b3"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-528-30)", "package_ndc": "72789-528-30", "marketing_start_date": "20250910"}], "brand_name": "Minocycline Hydrochloride", "product_id": "72789-528_3e794c61-ef94-8751-e063-6294a90aafc4", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Decreased Prothrombin Activity [PE]", "Tetracycline-class Drug [EPC]", "Tetracyclines [CS]"], "product_ndc": "72789-528", "generic_name": "Minocycline Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Minocycline Hydrochloride", "active_ingredients": [{"name": "MINOCYCLINE HYDROCHLORIDE", "strength": "105 mg/1"}], "application_number": "ANDA204453", "marketing_category": "ANDA", "marketing_start_date": "20160930", "listing_expiration_date": "20261231"}