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 · 6

ndc11
6838255201
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-01)
ndc11
6838255205
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-05)
ndc11
6838255206
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-06)
ndc11
6838255210
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-10)
ndc11
6838255216
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-16)
ndc11
6838255230
10 BLISTER PACK in 1 CARTON (68382-552-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

0020414E5U

MINOCYCLINE HYDROCHLORIDE

RxCUI 6979

Orange Book

A203553

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": "68382-552_d984bc89-8412-45fd-ba75-e707bc53ae3d",
  "productndc": "68382-552",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "203553",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 45MG BASE",
        "product_no": "001",
        "approval_date": "Nov 16, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 55MG BASE",
        "product_no": "002",
        "approval_date": "Jun 16, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 65MG BASE",
        "product_no": "003",
        "approval_date": "Jun 16, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 80MG BASE",
        "product_no": "004",
        "approval_date": "Nov 16, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 90MG BASE",
        "product_no": "005",
        "approval_date": "Nov 16, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 105MG BASE",
        "product_no": "006",
        "approval_date": "Nov 16, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 115MG BASE",
        "product_no": "007",
        "approval_date": "Jun 16, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 135MG BASE",
        "product_no": "008",
        "approval_date": "Nov 16, 2017"
      }
    ],
    "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": "ANDA203553",
  "marketing_category": "ANDA",
  "nonproprietary_name": "minocycline hydrochloride",
  "start_marketing_date": "20180307",
  "active_numerator_strength": "105"
}

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