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 TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

minocycline hydrochloride 105 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 68382-552
Product ID 68382-552_d984bc89-8412-45fd-ba75-e707bc53ae3d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203553
Listing Expiration 2026-12-31
Marketing Start 2018-03-07

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 68382552
Hyphenated Format 68382-552

Supplemental Identifiers

RxCUI
629695 629697 629699 858062 858372 1013659 1013662 1013665
UPC
0368382531063 0368382532060 0368382534064 0368382551061 0368382535061 0368382550064 0368382533067 0368382552068
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 ANDA203553 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 105 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-05)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-06)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-10)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-16)
  • 10 BLISTER PACK in 1 CARTON (68382-552-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (6)

68382-552-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-01) 68382-552-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-05) 68382-552-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-06) 68382-552-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-10) 68382-552-16 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-16) 68382-552-30 10 BLISTER PACK in 1 CARTON (68382-552-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

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": "d984bc89-8412-45fd-ba75-e707bc53ae3d", "openfda": {"upc": ["0368382531063", "0368382532060", "0368382534064", "0368382551061", "0368382535061", "0368382550064", "0368382533067", "0368382552068"], "unii": ["0020414E5U"], "rxcui": ["629695", "629697", "629699", "858062", "858372", "1013659", "1013662", "1013665"], "spl_set_id": ["85f082a5-bba1-4441-ba28-4b8ec9a537f2"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-01)", "package_ndc": "68382-552-01", "marketing_start_date": "20180307"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-05)", "package_ndc": "68382-552-05", "marketing_start_date": "20180307"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-06)", "package_ndc": "68382-552-06", "marketing_start_date": "20180307"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-10)", "package_ndc": "68382-552-10", "marketing_start_date": "20180307"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-16)", "package_ndc": "68382-552-16", "marketing_start_date": "20180307"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-552-30)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "68382-552-30", "marketing_start_date": "20180307"}], "brand_name": "minocycline hydrochloride", "product_id": "68382-552_d984bc89-8412-45fd-ba75-e707bc53ae3d", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Prothrombin Activity [PE]", "Tetracycline-class Drug [EPC]", "Tetracyclines [CS]"], "product_ndc": "68382-552", "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": "105 mg/1"}], "application_number": "ANDA203553", "marketing_category": "ANDA", "marketing_start_date": "20180307", "listing_expiration_date": "20261231"}