FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
66336-377
11-digit product format
663360377
Labeler code
66336
Product ID
66336-377_5c6c99d0-578e-49a1-847d-4b1f7cceaab6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Dispensing Solution, Inc.
Application
ANDA063065
Marketing category
ANDA
Marketing start
1991-12-30
Marketing end
0000-00-00
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
66336-377-142019-11-27C16284748780-19855d018-d6ee-cd31-e053-dbdaa90ab51aMinocycline Hydrochloride Capsules USP Revised: June 2009 Rx only 190791

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-377-14Minocycline Hydrochloride14 in 1 BOTTLE, PLASTICCAPSULE142

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66336-377-14EA - Each66336-377db08be7b-00dd-46ac-9acf-4ab9e51666a312013-07-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-377MINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]2Legacy NDC, 1 package rows20130625_ec1be1bf-73bb-41c5-8fab-359a4cc53674.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSNec1be1bf-73bb-41c5-8fab-359a4cc536742
197984minocycline 100 MG Oral CapsuleSCDec1be1bf-73bb-41c5-8fab-359a4cc536742
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYec1be1bf-73bb-41c5-8fab-359a4cc536742

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-377-146633603771414 in 1 BOTTLE, PLASTICHistorical