FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
65862-211
11-digit product format
658620211
Labeler code
65862
Product ID
65862-211_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
100 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 HYDROCHLORIDE100 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
65862-211-05Minocycline Hydrochloride500 in 1 BOTTLECAPSULE50015
65862-211-50Minocycline Hydrochloride50 in 1 BOTTLECAPSULE5015
65862-211-99Minocycline Hydrochloride1000 in 1 BOTTLECAPSULE100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-211-05EA - Each65862-211c6bbdb33-322a-4ddb-b0c8-791c2803340012015-10-02
65862-211-50EA - Each65862-211ce7e8420-d797-4069-a7da-10426c742a2112012-07-24

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
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]1
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]1
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
GELATININACTIVE INGREDIENT2G86QN327LMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
SHELLACINACTIVE INGREDIENT46N107B71OMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-211MINOCYCLINE 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
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 CapsulePSN0becbde8-6ec5-4830-a0d9-cfdb7b15eb8416
197984minocycline 100 MG Oral CapsuleSCD0becbde8-6ec5-4830-a0d9-cfdb7b15eb8416
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY0becbde8-6ec5-4830-a0d9-cfdb7b15eb8416
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
197984minocycline HCl 100 MG Oral CapsulePSNcaa99901-467c-4e99-b7e9-fbabdf5d118c8
197984minocycline 100 MG Oral CapsuleSCDcaa99901-467c-4e99-b7e9-fbabdf5d118c8
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYcaa99901-467c-4e99-b7e9-fbabdf5d118c8
197984minocycline HCl 100 MG Oral CapsulePSNbb3b9a7e-6724-4c2a-b3cb-236f522b31a86
197984minocycline 100 MG Oral CapsuleSCDbb3b9a7e-6724-4c2a-b3cb-236f522b31a86
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYbb3b9a7e-6724-4c2a-b3cb-236f522b31a86
197984minocycline HCl 100 MG Oral CapsulePSN12559b29-6568-4b99-a16e-6a87038981f75
197984minocycline 100 MG Oral CapsuleSCD12559b29-6568-4b99-a16e-6a87038981f75
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY12559b29-6568-4b99-a16e-6a87038981f75
197984minocycline HCl 100 MG Oral CapsulePSN4f904969-5af3-461e-b557-d03a1e5c72924
197984minocycline HCl 100 MG Oral CapsulePSNabaacdeb-2433-261a-e053-2995a90ae34e4
197984minocycline 100 MG Oral CapsuleSCDabaacdeb-2433-261a-e053-2995a90ae34e4
197984minocycline 100 MG Oral CapsuleSCD4f904969-5af3-461e-b557-d03a1e5c72924
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYabaacdeb-2433-261a-e053-2995a90ae34e4
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY4f904969-5af3-461e-b557-d03a1e5c72924
197984minocycline HCl 100 MG Oral CapsulePSN174d642b-70b1-45b0-ad33-a4847feb1a8f3
197984minocycline 100 MG Oral CapsuleSCD174d642b-70b1-45b0-ad33-a4847feb1a8f3
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY174d642b-70b1-45b0-ad33-a4847feb1a8f3
197984minocycline HCl 100 MG Oral CapsulePSN192327c5-d2bc-1bd1-e063-6394a90a110b1
197984minocycline 100 MG Oral CapsuleSCD192327c5-d2bc-1bd1-e063-6394a90a110b1
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY192327c5-d2bc-1bd1-e063-6394a90a110b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-211-0565862021105500 CAPSULE in 1 BOTTLE (65862-211-05) 500 capsule2008-03-110000-00-00NoNoCurrent
65862-211-506586202115050 CAPSULE in 1 BOTTLE (65862-211-50) 50 capsule2008-03-110000-00-00NoNoCurrent
65862-211-99658620211991000 CAPSULE in 1 BOTTLE (65862-211-99) 1000 capsule2008-03-110000-00-00NoNoCurrent