FDA.reportPublic FDA data

Minocycline hydrochloride

Product NDC
63304-694
11-digit product format
633040694
Labeler code
63304
Product ID
63304-694_1ffca7b6-8f19-4a26-9578-cbdd72296068
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Ranbaxy Pharmaceuticals Inc.
Application
ANDA065062
Marketing category
ANDA
Marketing start
2000-12-22
Marketing end
0000-00-00
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63304-694-012020-01-31C16284748780-19d75b9d0-2359-f424-e053-dadaa90a57ce61f1d07a-f5e9-45b5-8806-b31a441bc592
63304-694-052020-01-31C16284748780-19d75b9d0-2359-f424-e053-dadaa90a57ce61f1d07a-f5e9-45b5-8806-b31a441bc592

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-694-01Minocycline hydrochloride100 in 1 BOTTLECAPSULE1004
63304-694-05Minocycline hydrochloride500 in 1 BOTTLECAPSULE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-694-01EA - Each63304-6942f2340de-5466-4685-b892-b4856374bfe312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]5
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MINOCYCLINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]5
GELATININACTIVE INGREDIENT2G86QN327LMINOCYCLINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]5
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TMINOCYCLINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MINOCYCLINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]5
SHELLACINACTIVE INGREDIENT46N107B71OMINOCYCLINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOCYCLINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]5
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE CAPSULE [RANBAXY PHARMACEUTICALS INC.]4
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE [RANBAXY PHARMACEUTICALS INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MINOCYCLINE HYDROCHLORIDE CAPSULE [RANBAXY PHARMACEUTICALS INC.]4
GELATININACTIVE INGREDIENT2G86QN327LMINOCYCLINE HYDROCHLORIDE CAPSULE [RANBAXY PHARMACEUTICALS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE CAPSULE [RANBAXY PHARMACEUTICALS INC.]4
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TMINOCYCLINE HYDROCHLORIDE CAPSULE [RANBAXY PHARMACEUTICALS INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MINOCYCLINE HYDROCHLORIDE CAPSULE [RANBAXY PHARMACEUTICALS INC.]4
SHELLACINACTIVE INGREDIENT46N107B71OMINOCYCLINE HYDROCHLORIDE CAPSULE [RANBAXY PHARMACEUTICALS INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOCYCLINE HYDROCHLORIDE CAPSULE [RANBAXY PHARMACEUTICALS INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE CAPSULE [RANBAXY PHARMACEUTICALS INC.]4
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]2
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MINOCYCLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]2
GELATININACTIVE INGREDIENT2G86QN327LMINOCYCLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TMINOCYCLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MINOCYCLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]2
SHELLACINACTIVE INGREDIENT46N107B71OMINOCYCLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOCYCLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]2
minocycline hydrochlorideACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP.]1
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
minocyclineACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP.]1
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MINOCYCLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MINOCYCLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
gelatinINACTIVE INGREDIENT2G86QN327LMINOCYCLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP.]1
GELATININACTIVE INGREDIENT2G86QN327LMINOCYCLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TMINOCYCLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MINOCYCLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OMINOCYCLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOCYCLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOCYCLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-694MINOCYCLINE HYDROCHLORIDE CAPSULE [RANBAXY PHARMACEUTICALS INC.]4Legacy NDC, 2 package rows20140602_61f1d07a-f5e9-45b5-8806-b31a441bc592.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSNe6b04358-0f4c-4b21-a7f3-320d1e7bc0b85
197984minocycline HCl 100 MG Oral CapsulePSNc635af0d-b005-4bce-8c43-24d0508c28ad5
197985minocycline HCl 50 MG Oral CapsulePSNe6b04358-0f4c-4b21-a7f3-320d1e7bc0b85
197985minocycline HCl 50 MG Oral CapsulePSNc635af0d-b005-4bce-8c43-24d0508c28ad5
314108minocycline HCl 75 MG Oral CapsulePSNc635af0d-b005-4bce-8c43-24d0508c28ad5
197984minocycline 100 MG Oral CapsuleSCDe6b04358-0f4c-4b21-a7f3-320d1e7bc0b85
197984minocycline 100 MG Oral CapsuleSCDc635af0d-b005-4bce-8c43-24d0508c28ad5
197985minocycline 50 MG Oral CapsuleSCDe6b04358-0f4c-4b21-a7f3-320d1e7bc0b85
197985minocycline 50 MG Oral CapsuleSCDc635af0d-b005-4bce-8c43-24d0508c28ad5
314108minocycline 75 MG Oral CapsuleSCDc635af0d-b005-4bce-8c43-24d0508c28ad5
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYe6b04358-0f4c-4b21-a7f3-320d1e7bc0b85
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYc635af0d-b005-4bce-8c43-24d0508c28ad5
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSYc635af0d-b005-4bce-8c43-24d0508c28ad5
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSYe6b04358-0f4c-4b21-a7f3-320d1e7bc0b85
314108minocycline (as minocycline hydrochloride) 75 MG Oral CapsuleSYc635af0d-b005-4bce-8c43-24d0508c28ad5
197984minocycline HCl 100 MG Oral CapsulePSN61f1d07a-f5e9-45b5-8806-b31a441bc5924
197985minocycline HCl 50 MG Oral CapsulePSN61f1d07a-f5e9-45b5-8806-b31a441bc5924
314108minocycline HCl 75 MG Oral CapsulePSN61f1d07a-f5e9-45b5-8806-b31a441bc5924
197984minocycline 100 MG Oral CapsuleSCD61f1d07a-f5e9-45b5-8806-b31a441bc5924
197985minocycline 50 MG Oral CapsuleSCD61f1d07a-f5e9-45b5-8806-b31a441bc5924
314108minocycline 75 MG Oral CapsuleSCD61f1d07a-f5e9-45b5-8806-b31a441bc5924
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY61f1d07a-f5e9-45b5-8806-b31a441bc5924
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSY61f1d07a-f5e9-45b5-8806-b31a441bc5924
314108minocycline (as minocycline hydrochloride) 75 MG Oral CapsuleSY61f1d07a-f5e9-45b5-8806-b31a441bc5924
197985minocycline HCl 50 MG Oral CapsulePSN25c3fe66-ab93-47e0-e054-00144ff8d46c2
197985minocycline 50 MG Oral CapsuleSCD25c3fe66-ab93-47e0-e054-00144ff8d46c2
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSY25c3fe66-ab93-47e0-e054-00144ff8d46c2
197984minocycline HCl 100 MG Oral CapsulePSN4d2c1b40-12bb-47c6-9466-fc2de10940f31
197985minocycline HCl 50 MG Oral CapsulePSNa74f9195-8a43-428f-9262-a41313165e0a1
197985minocycline HCl 50 MG Oral CapsulePSN4d2c1b40-12bb-47c6-9466-fc2de10940f31
197984minocycline 100 MG Oral CapsuleSCD4d2c1b40-12bb-47c6-9466-fc2de10940f31
197985minocycline 50 MG Oral CapsuleSCDa74f9195-8a43-428f-9262-a41313165e0a1
197985minocycline 50 MG Oral CapsuleSCD4d2c1b40-12bb-47c6-9466-fc2de10940f31
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY4d2c1b40-12bb-47c6-9466-fc2de10940f31
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSYa74f9195-8a43-428f-9262-a41313165e0a1
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSY4d2c1b40-12bb-47c6-9466-fc2de10940f31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63304-694-0163304069401100 in 1 BOTTLEHistorical
63304-694-0563304069405500 in 1 BOTTLEHistorical