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United States · US · US:72789-525_3e74d98b-05cb-180f-e063-6294a90ac0b5
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 · 1
- ndc11727895253030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-525-30)
Annotations
UNII (FDA Substance ID)
0020414E5U
MINOCYCLINE HYDROCHLORIDE
RxCUI 6979
Orange Book
A204453
ABABABABABABABAB
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": "72789-525_3e74d98b-05cb-180f-e063-6294a90ac0b5",
"productndc": "72789-525",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "204453",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 45MG BASE",
"product_no": "001",
"approval_date": "Sep 28, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 80MG BASE",
"product_no": "002",
"approval_date": "Sep 28, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 90MG BASE",
"product_no": "003",
"approval_date": "Sep 28, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 105MG BASE",
"product_no": "004",
"approval_date": "Sep 28, 2016"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "EQ 135MG BASE",
"product_no": "005",
"approval_date": "Sep 28, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 65MG BASE",
"product_no": "006",
"approval_date": "Mar 16, 2018"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "EQ 115MG BASE",
"product_no": "007",
"approval_date": "Mar 16, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 55MG BASE",
"product_no": "008",
"approval_date": "Dec 19, 2019"
}
],
"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": "ANDA204453",
"marketing_category": "ANDA",
"nonproprietary_name": "Minocycline Hydrochloride",
"start_marketing_date": "20160930",
"active_numerator_strength": "90"
}Related drugs
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