Minocycline hydrochloride

Orange BookUNIISPLATC A01AB23

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeA01AB23

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6838231818
50 CAPSULE in 1 BOTTLE (68382-318-18)

Annotations

UNII (FDA Substance ID)

0020414E5U

MINOCYCLINE HYDROCHLORIDE

RxCUI 6979

Orange Book

A063009

ABAB

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": "68382-318_0c236c6b-5f2a-4b46-a12f-45c47b90b65a",
  "productndc": "68382-318",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "063009",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Mar 2, 1992"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "002",
        "approval_date": "Aug 12, 2003"
      }
    ],
    "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": "ANDA063009",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Minocycline hydrochloride",
  "start_marketing_date": "20170403",
  "active_numerator_strength": "100"
}

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