Minocycline Hydrochloride

Orange BookUNIISPLATC A01AB23

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeA01AB23

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
5528920114
14 CAPSULE in 1 BOTTLE, PLASTIC (55289-201-14)
ndc11
5528920120
20 CAPSULE in 1 BOTTLE, PLASTIC (55289-201-20)
ndc11
5528920130
30 CAPSULE in 1 BOTTLE, PLASTIC (55289-201-30)

Annotations

UNII (FDA Substance ID)

0020414E5U

MINOCYCLINE HYDROCHLORIDE

RxCUI 6979

Orange Book

A063065

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": "55289-201_2abe5cd1-1aa6-fab2-e063-6294a90a8abe",
  "productndc": "55289-201",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "063065",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Dec 30, 1991"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "002",
        "approval_date": "Jun 10, 1999"
      }
    ],
    "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": "ANDA063065",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Minocycline Hydrochloride",
  "start_marketing_date": "19930501",
  "active_numerator_strength": "100"
}

Related drugs

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