Minocycline Hydrochloride

Orange BookUNIISPLATC A01AB23

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeA01AB23

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6586255401
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-554-01)
ndc11
6586255430
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-554-30)
ndc11
6586255499
1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-554-99)

Annotations

UNII (FDA Substance ID)

0020414E5U

MINOCYCLINE HYDROCHLORIDE

RxCUI 6979

Orange Book

A202261

ABABABABABABABAB

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": "65862-554_5569f0f6-b36f-4149-aee7-2699fa5ebe53",
  "productndc": "65862-554",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "202261",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 45MG BASE",
        "product_no": "001",
        "approval_date": "Nov 19, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 65MG BASE",
        "product_no": "002",
        "approval_date": "Sep 28, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 90MG BASE",
        "product_no": "003",
        "approval_date": "Nov 19, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 115MG BASE",
        "product_no": "004",
        "approval_date": "Sep 28, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 135MG BASE",
        "product_no": "005",
        "approval_date": "Nov 19, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 80MG BASE",
        "product_no": "006",
        "approval_date": "Jun 13, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 105MG BASE",
        "product_no": "007",
        "approval_date": "Jun 13, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 55MG BASE",
        "product_no": "008",
        "approval_date": "Aug 21, 2019"
      }
    ],
    "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": "ANDA202261",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Minocycline Hydrochloride",
  "start_marketing_date": "20121119",
  "active_numerator_strength": "45"
}

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