FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
65862-209
11-digit product format
658620209
Labeler code
65862
Product ID
65862-209_2f124ba7-5911-4813-be26-f7f0438d129c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA065470
Marketing category
ANDA
Marketing start
2008-03-11
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Minocycline Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOCYCLINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0020414E5U
Rxcui197984, 197985, 314108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9c90ddb-dcc8-42af-a94b-505e4488bdc7Product name120250623
9e423e97-a6d9-7bb0-0dcb-343af7c0ff92Product name220230322
472a6924-c7ed-850b-32ce-a510e887fbf9Product name420230207
f1239550-2d2e-44c3-aec7-14fd9b4ab55dProduct name120201103
7a57513a-a145-4b95-9165-1e0ef21d6017Product name120200326
70555e58-6951-4421-9354-f80c6ce0d92cProduct name720200204
23de08d7-aa4e-ec8b-ce6d-2124a855e4efProduct name520180605
76736e48-254d-4a39-993d-206efbdaad1dProduct name120170717
0c498039-5512-d9d7-e6b6-833de47219ffProduct name220151106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-209-01Minocycline Hydrochloride100 in 1 BOTTLECAPSULE10015
65862-209-05Minocycline Hydrochloride500 in 1 BOTTLECAPSULE50015
65862-209-99Minocycline Hydrochloride1000 in 1 BOTTLECAPSULE100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-209-01EA - Each65862-209096fef42-0694-4a8c-9292-aba06e6d0ca512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]6
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]6
ALCOHOLINACTIVE INGREDIENT3K9958V90MMINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]6
AMMONIAINACTIVE INGREDIENT5138Q19F1XMINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]6
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]6
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]6
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LMINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]6
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYMINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]6
GELATININACTIVE INGREDIENT2G86QN327LMINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]6
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]6
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TMINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]6
SHELLACINACTIVE INGREDIENT46N107B71OMINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-209MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]15Current NDC, Legacy NDC, 3 package rows20250426_9013ca48-15f2-43cd-a51d-91cf65c72a7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197985minocycline HCl 50 MG Oral CapsulePSNa6224eeb-25be-4f1d-889f-809aaf338c8c102
197985minocycline 50 MG Oral CapsuleSCDa6224eeb-25be-4f1d-889f-809aaf338c8c102
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSYa6224eeb-25be-4f1d-889f-809aaf338c8c102
197984minocycline HCl 100 MG Oral CapsulePSNc96b1c5d-7004-4ee2-ad48-0ba963389f8628
197985minocycline HCl 50 MG Oral CapsulePSNc96b1c5d-7004-4ee2-ad48-0ba963389f8628
197984minocycline 100 MG Oral CapsuleSCDc96b1c5d-7004-4ee2-ad48-0ba963389f8628
197985minocycline 50 MG Oral CapsuleSCDc96b1c5d-7004-4ee2-ad48-0ba963389f8628
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYc96b1c5d-7004-4ee2-ad48-0ba963389f8628
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSYc96b1c5d-7004-4ee2-ad48-0ba963389f8628
197984minocycline HCl 100 MG Oral CapsulePSN9013ca48-15f2-43cd-a51d-91cf65c72a7c15
197985minocycline HCl 50 MG Oral CapsulePSN9013ca48-15f2-43cd-a51d-91cf65c72a7c15
314108minocycline HCl 75 MG Oral CapsulePSN9013ca48-15f2-43cd-a51d-91cf65c72a7c15
197984minocycline 100 MG Oral CapsuleSCD9013ca48-15f2-43cd-a51d-91cf65c72a7c15
197985minocycline 50 MG Oral CapsuleSCD9013ca48-15f2-43cd-a51d-91cf65c72a7c15
314108minocycline 75 MG Oral CapsuleSCD9013ca48-15f2-43cd-a51d-91cf65c72a7c15
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY9013ca48-15f2-43cd-a51d-91cf65c72a7c15
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSY9013ca48-15f2-43cd-a51d-91cf65c72a7c15
314108minocycline (as minocycline hydrochloride) 75 MG Oral CapsuleSY9013ca48-15f2-43cd-a51d-91cf65c72a7c15
197985minocycline HCl 50 MG Oral CapsulePSNb620fc3d-bada-a58f-e053-2995a90ab28d3
197985minocycline 50 MG Oral CapsuleSCDb620fc3d-bada-a58f-e053-2995a90ab28d3
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSYb620fc3d-bada-a58f-e053-2995a90ab28d3
197985minocycline HCl 50 MG Oral CapsulePSN8a80a7b8-4068-5d38-e053-2995a90a3f1d1
197985minocycline 50 MG Oral CapsuleSCD8a80a7b8-4068-5d38-e053-2995a90a3f1d1
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSY8a80a7b8-4068-5d38-e053-2995a90a3f1d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-209-0165862020901100 CAPSULE in 1 BOTTLE (65862-209-01) 100 capsule2008-03-110000-00-00NoNoCurrent
65862-209-0565862020905500 CAPSULE in 1 BOTTLE (65862-209-05) 500 capsule2008-03-110000-00-00NoNoCurrent
65862-209-99658620209991000 CAPSULE in 1 BOTTLE (65862-209-99) 1000 capsule2008-03-110000-00-00NoNoCurrent