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United States · US · US:70771-1138_5f19958c-a2d2-4ef1-accd-17186e623625

minocycline hydrochloride

Orange BookUNIISPLATC A01AB23

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeA01AB23
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    7077111380
    1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1138-0)
  • ndc11
    7077111381
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1138-1)
  • ndc11
    7077111383
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1138-3)
  • ndc11
    7077111385
    500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1138-5)
  • ndc11
    7077111387
    10 BLISTER PACK in 1 CARTON (70771-1138-7) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    7077111389
    90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1138-9)

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": "70771-1138_5f19958c-a2d2-4ef1-accd-17186e623625",
  "productndc": "70771-1138",
  "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": "45"
}

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