FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
0591-3153
11-digit product format
005913153
Labeler code
0591
Product ID
0591-3153_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
2002-09-17
Marketing end
2026-07-31
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
75 mg/1
Pharmacologic classes
Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Minocycline Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOCYCLINE HYDROCHLORIDE75 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
0591-3153-01Minocycline Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE10023

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3153MINOCYCLINE 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
314108minocycline HCl 75 MG Oral CapsulePSN6f154720-706e-4177-8167-1bc893303f1b1003
314108minocycline 75 MG Oral CapsuleSCD6f154720-706e-4177-8167-1bc893303f1b1003
314108minocycline (as minocycline hydrochloride) 75 MG Oral CapsuleSY6f154720-706e-4177-8167-1bc893303f1b1003
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-3153-000059131530039840 CAPSULE in 1 BOX (0591-3153-00)39840 capsule10-JUN-99Current
0591-3153-0100591315301100 CAPSULE in 1 BOTTLE, PLASTIC (0591-3153-01) 100 capsule2002-09-172026-07-31NoNoCurrent