Minocycline Hydrochloride

Orange BookUNIISPLATC A01AB23

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

Identification

ManufacturerLupin Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeA01AB23

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)

0020414E5U

MINOCYCLINE HYDROCHLORIDE

RxCUI 6979

Orange Book

A091424

ABABABAB

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": "68180-381_ad320f99-9382-4ef0-b6b6-86542020555a",
  "productndc": "68180-381",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "091424",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 45MG BASE",
        "product_no": "001",
        "approval_date": "Nov 30, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 55MG BASE",
        "product_no": "002",
        "approval_date": "Nov 30, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 90MG BASE",
        "product_no": "003",
        "approval_date": "Nov 30, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 135MG BASE",
        "product_no": "004",
        "approval_date": "Nov 30, 2011"
      }
    ],
    "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": "ANDA091424",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Minocycline Hydrochloride",
  "start_marketing_date": "20120214",
  "active_numerator_strength": "135"
}

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