FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
0591-5695
11-digit product format
005915695
Labeler code
0591
Product ID
0591-5695_2d74faa2-99c4-4f01-adc6-60110d2b24da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA063065
Marketing category
ANDA
Marketing start
1993-05-01
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
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
0591-5695-50Minocycline Hydrochloride50 in 1 BOTTLE, PLASTICCAPSULE5023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-5695-50EA - Each0591-569548a683af-f89a-4338-876f-c554e627c9cf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]15
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]15
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]15
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]15
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]15
GELATININACTIVE INGREDIENT2G86QN327LMINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]15
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]15
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]15
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]15
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]12
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]12
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]12
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]12
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]12
GELATININACTIVE INGREDIENT2G86QN327LMINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]12
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]12
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]2
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]2
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMINOCYCLINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMINOCYCLINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MINOCYCLINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LMINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LMINOCYCLINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MINOCYCLINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMINOCYCLINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOCYCLINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5695MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]21Current NDC, Legacy NDC, 1 package rows20241006_a5fc4d50-50b2-46e0-b722-4c6b2ec47d06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSN87a137c6-dd53-44d3-ab49-ef78ebed35c827
197984minocycline 100 MG Oral CapsuleSCD87a137c6-dd53-44d3-ab49-ef78ebed35c827
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY87a137c6-dd53-44d3-ab49-ef78ebed35c827
197984minocycline HCl 100 MG Oral CapsulePSNa5fc4d50-50b2-46e0-b722-4c6b2ec47d0623
197985minocycline HCl 50 MG Oral CapsulePSNa5fc4d50-50b2-46e0-b722-4c6b2ec47d0623
314108minocycline HCl 75 MG Oral CapsulePSNa5fc4d50-50b2-46e0-b722-4c6b2ec47d0623
197984minocycline 100 MG Oral CapsuleSCDa5fc4d50-50b2-46e0-b722-4c6b2ec47d0623
197985minocycline 50 MG Oral CapsuleSCDa5fc4d50-50b2-46e0-b722-4c6b2ec47d0623
314108minocycline 75 MG Oral CapsuleSCDa5fc4d50-50b2-46e0-b722-4c6b2ec47d0623
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYa5fc4d50-50b2-46e0-b722-4c6b2ec47d0623
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSYa5fc4d50-50b2-46e0-b722-4c6b2ec47d0623
314108minocycline (as minocycline hydrochloride) 75 MG Oral CapsuleSYa5fc4d50-50b2-46e0-b722-4c6b2ec47d0623
197984minocycline HCl 100 MG Oral CapsulePSN4eca4036-ba54-408e-e054-00144ff8d46c3
197984minocycline 100 MG Oral CapsuleSCD4eca4036-ba54-408e-e054-00144ff8d46c3
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY4eca4036-ba54-408e-e054-00144ff8d46c3
197984minocycline HCl 100 MG Oral CapsulePSN00bf1ab3-dd22-439d-85fb-966dbb76c9002
197984minocycline HCl 100 MG Oral CapsulePSNa84c29a9-21a8-4965-b5a5-37b28e4af5a02
197984minocycline HCl 100 MG Oral CapsulePSNec1be1bf-73bb-41c5-8fab-359a4cc536742
197985minocycline HCl 50 MG Oral CapsulePSNa84c29a9-21a8-4965-b5a5-37b28e4af5a02
197984minocycline 100 MG Oral CapsuleSCDa84c29a9-21a8-4965-b5a5-37b28e4af5a02
197984minocycline 100 MG Oral CapsuleSCDec1be1bf-73bb-41c5-8fab-359a4cc536742
197984minocycline 100 MG Oral CapsuleSCD00bf1ab3-dd22-439d-85fb-966dbb76c9002
197985minocycline 50 MG Oral CapsuleSCDa84c29a9-21a8-4965-b5a5-37b28e4af5a02
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYa84c29a9-21a8-4965-b5a5-37b28e4af5a02
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY00bf1ab3-dd22-439d-85fb-966dbb76c9002
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYec1be1bf-73bb-41c5-8fab-359a4cc536742
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSYa84c29a9-21a8-4965-b5a5-37b28e4af5a02
197984minocycline HCl 100 MG Oral CapsulePSN6597bdc9-9e3a-4c11-8b39-27b47f8632871
197984minocycline 100 MG Oral CapsuleSCD6597bdc9-9e3a-4c11-8b39-27b47f8632871
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY6597bdc9-9e3a-4c11-8b39-27b47f8632871

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-5695-000059156950030210 CAPSULE in 1 BOX (0591-5695-00)30210 capsule30-DEC-91Current
0591-5695-500059156955050 CAPSULE in 1 BOTTLE, PLASTIC (0591-5695-50) 50 capsule1993-05-010000-00-00NoNoCurrent
0591-5695-770059156957730210 CAPSULE in 1 CONTAINER (0591-5695-77)30210 capsule16-OCT-24Current