Minocycline Hydrochloride

Orange BookUNIISPLATC A01AB23

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC

CountryUS (United States)

ATC codeA01AB23

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
8042503901
30 CAPSULE in 1 BOTTLE (80425-0390-1)
ndc11
8042503902
60 CAPSULE in 1 BOTTLE (80425-0390-2)
ndc11
8042503903
90 CAPSULE in 1 BOTTLE (80425-0390-3)

Annotations

UNII (FDA Substance ID)

0020414E5U

MINOCYCLINE HYDROCHLORIDE

RxCUI 6979

Orange Book

A065470

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "0020414E5U",
    "rxcui": "6979",
    "inchikey": "GLMUAFMGXXHGLU-VQAITOIOSA-N",
    "display_name": "MINOCYCLINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "7e2390b7-242c-43ff-afb3-b0a5e79351d3": {
      "match": "brand_token",
      "title": "MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "27",
      "published_date": "2026-05-15"
    }
  },
  "productid": "80425-0390_19233bc0-9973-2002-e063-6394a90a057c",
  "productndc": "80425-0390",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "065470",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Mar 11, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "002",
        "approval_date": "Mar 11, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "Mar 11, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MINOCYCLINE HYDROCHLORIDE",
  "proprietary_name": "Minocycline Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065470",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Minocycline Hydrochloride",
  "start_marketing_date": "20240523",
  "active_numerator_strength": "100"
}

Related drugs

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