FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
0591-5694
11-digit product format
005915694
Labeler code
0591
Product ID
0591-5694_2d74faa2-99c4-4f01-adc6-60110d2b24da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA063181
Marketing category
ANDA
Marketing start
1992-02-01
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
0591-5694-01Minocycline Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE10023
0591-5694-60Minocycline Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE6023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-5694-01EA - Each0591-569473ee5be7-4ba2-41c3-91fe-78ace45da7ad12012-07-24
0591-5694-60EA - Each0591-56940681675e-3234-4d83-8eb6-410dafed229c12012-07-24

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.]10
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
GELATININACTIVE INGREDIENT2G86QN327LMINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5694MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]21Current NDC, Legacy NDC, 2 package rows20241006_a5fc4d50-50b2-46e0-b722-4c6b2ec47d06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197985minocycline HCl 50 MG Oral CapsulePSN1ec20539-0421-4eac-95ed-e9acc6329fd027
197985minocycline 50 MG Oral CapsuleSCD1ec20539-0421-4eac-95ed-e9acc6329fd027
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSY1ec20539-0421-4eac-95ed-e9acc6329fd027
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
197985minocycline HCl 50 MG Oral CapsulePSNf4b434e3-31c2-4e5b-8dff-9bc4636d97905
197985minocycline HCl 50 MG Oral CapsulePSNd5fcba91-6aa6-4072-aea5-fb8da65d9aac5
197985minocycline 50 MG Oral CapsuleSCDd5fcba91-6aa6-4072-aea5-fb8da65d9aac5
197985minocycline 50 MG Oral CapsuleSCDf4b434e3-31c2-4e5b-8dff-9bc4636d97905
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSYd5fcba91-6aa6-4072-aea5-fb8da65d9aac5
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSYf4b434e3-31c2-4e5b-8dff-9bc4636d97905
197985minocycline HCl 50 MG Oral CapsulePSN2b5f951e-4b70-2c1f-e054-00144ff8d46c3
197985minocycline 50 MG Oral CapsuleSCD2b5f951e-4b70-2c1f-e054-00144ff8d46c3
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSY2b5f951e-4b70-2c1f-e054-00144ff8d46c3
197984minocycline HCl 100 MG Oral CapsulePSNa84c29a9-21a8-4965-b5a5-37b28e4af5a02
197985minocycline HCl 50 MG Oral CapsulePSNa84c29a9-21a8-4965-b5a5-37b28e4af5a02
197984minocycline 100 MG Oral CapsuleSCDa84c29a9-21a8-4965-b5a5-37b28e4af5a02
197985minocycline 50 MG Oral CapsuleSCDa84c29a9-21a8-4965-b5a5-37b28e4af5a02
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYa84c29a9-21a8-4965-b5a5-37b28e4af5a02
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSYa84c29a9-21a8-4965-b5a5-37b28e4af5a02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-5694-0100591569401100 CAPSULE in 1 BOTTLE, PLASTIC (0591-5694-01) 100 capsule1992-02-010000-00-00NoNoCurrent
0591-5694-600059156946060 CAPSULE in 1 BOTTLE, PLASTIC (0591-5694-60) 60 capsule2006-05-250000-00-00NoNoCurrent