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United States · US · US:43063-736_51b57b3d-2319-ef81-e063-6294a90a77d8

Minocycline Hydrochloride

Orange BookUNIISPLATC A01AB23

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA01AB23
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    4306373614
    14 CAPSULE in 1 BOTTLE, PLASTIC (43063-736-14)
  • ndc11
    4306373620
    20 CAPSULE in 1 BOTTLE, PLASTIC (43063-736-20)
  • ndc11
    4306373630
    30 CAPSULE in 1 BOTTLE, PLASTIC (43063-736-30)
  • ndc11
    4306373660
    60 CAPSULE in 1 BOTTLE, PLASTIC (43063-736-60)

Annotations

UNII (FDA Substance ID)
0020414E5U
MINOCYCLINE HYDROCHLORIDE
RxCUI 6979
Orange Book
A065062
ABABAB
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": "43063-736_51b57b3d-2319-ef81-e063-6294a90a77d8",
  "productndc": "43063-736",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "065062",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Nov 30, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "002",
        "approval_date": "Nov 30, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "Nov 30, 2000"
      }
    ],
    "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": "ANDA065062",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Minocycline Hydrochloride",
  "start_marketing_date": "20150402",
  "active_numerator_strength": "100"
}

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