Minocycline Hydrochloride

Product NDC
63304-697
11-digit product format
633040697
Labeler code
63304
Product ID
63304-697_4a8d201f-b0b6-4463-af35-8f241caf048b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ranbaxy Pharmaceuticals Inc.
Application
ANDA065156
Marketing category
ANDA
Marketing start
2004-06-29
Marketing end
0000-00-00
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
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
63304-697-012020-01-31C16284748780-19d75b9cf-d790-f424-e053-dadaa90a57ceb4db7cdc-bcad-4825-9840-6c36246c6d31
63304-697-052020-01-31C16284748780-19d75b9cf-d790-f424-e053-dadaa90a57ceb4db7cdc-bcad-4825-9840-6c36246c6d31

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-697-01Minocycline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1004
63304-697-05Minocycline Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-697-01EA - Each63304-697bddae9c1-6609-413f-8ab6-d7d551a6243d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-697MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE) TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4Legacy NDC, 2 package rows20111025_b4db7cdc-bcad-4825-9840-6c36246c6d31.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
207364minocycline HCl 100 MG Oral TabletPSNb4db7cdc-bcad-4825-9840-6c36246c6d314
207362minocycline HCl 50 MG Oral TabletPSNb4db7cdc-bcad-4825-9840-6c36246c6d314
403840minocycline HCl 75 MG Oral TabletPSNb4db7cdc-bcad-4825-9840-6c36246c6d314
207364minocycline 100 MG Oral TabletSCDb4db7cdc-bcad-4825-9840-6c36246c6d314
207362minocycline 50 MG Oral TabletSCDb4db7cdc-bcad-4825-9840-6c36246c6d314
403840minocycline 75 MG Oral TabletSCDb4db7cdc-bcad-4825-9840-6c36246c6d314
207364minocycline (as minocycline hydrochloride) 100 MG Oral TabletSYb4db7cdc-bcad-4825-9840-6c36246c6d314
207362minocycline (as minocycline hydrochloride) 50 MG Oral TabletSYb4db7cdc-bcad-4825-9840-6c36246c6d314
403840minocycline (as minocycline hydrochloride) 75 MG Oral TabletSYb4db7cdc-bcad-4825-9840-6c36246c6d314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63304-697-0163304069701100 in 1 BOTTLEHistorical
63304-697-0563304069705500 in 1 BOTTLEHistorical