minocycline hydrochloride

Generic: minocycline hydrochloride

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name minocycline hydrochloride
Generic Name minocycline hydrochloride
Labeler ascend laboratories, llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

minocycline hydrochloride 105 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-438
Product ID 67877-438_51213aa1-873c-4b55-a36d-3ebbb73fa220
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 67877438
Hyphenated Format 67877-438

Supplemental Identifiers

RxCUI
629695 629697 629699 858062 858372 1013659 1013662 1013665
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 ANDA204453 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 105 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-438-01)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-438-05)
  • 10 BLISTER PACK in 1 CARTON (67877-438-14) / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-438-30)
source: ndc

Packages (4)

67877-438-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-438-01) 67877-438-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-438-05) 67877-438-14 10 BLISTER PACK in 1 CARTON (67877-438-14) / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 67877-438-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-438-30)

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": "51213aa1-873c-4b55-a36d-3ebbb73fa220", "openfda": {"unii": ["0020414E5U"], "rxcui": ["629695", "629697", "629699", "858062", "858372", "1013659", "1013662", "1013665"], "spl_set_id": ["a8f95207-b259-4f50-87f2-3652d9268890"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-438-01)", "package_ndc": "67877-438-01", "marketing_start_date": "20160930"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-438-05)", "package_ndc": "67877-438-05", "marketing_start_date": "20160930"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (67877-438-14)  / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "67877-438-14", "marketing_start_date": "20160930"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-438-30)", "package_ndc": "67877-438-30", "marketing_start_date": "20160930"}], "brand_name": "Minocycline Hydrochloride", "product_id": "67877-438_51213aa1-873c-4b55-a36d-3ebbb73fa220", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Decreased Prothrombin Activity [PE]", "Tetracycline-class Drug [EPC]", "Tetracyclines [CS]"], "product_ndc": "67877-438", "generic_name": "Minocycline Hydrochloride", "labeler_name": "Ascend Laboratories, LLC", "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"}