Minocycline Hydrochloride

Product NDC
55111-637
11-digit product format
551110637
Labeler code
55111
Product ID
55111-637_ce7fa22b-68f0-23fb-6ee0-121a41f01ca7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA065436
Marketing category
ANDA
Marketing start
2008-01-23
Marketing end
0000-00-00
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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
55111-637-012025-01-30C16284748780-12cef2736-8c23-d83d-e063-dadaa90ab31faec056cd-4f1f-4971-2bea-0b05ee028889
55111-637-102025-01-30C16284748780-12cef2736-8c23-d83d-e063-dadaa90ab31faec056cd-4f1f-4971-2bea-0b05ee028889

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-637-01Minocycline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1008
55111-637-10Minocycline Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-637-01EA - Each55111-637495418d7-d621-4713-b283-2413e70744b312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Minocycline HydrochlorideACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
MinocyclineACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
Cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKMINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
FD&C Yellow No. 5INACTIVE INGREDIENTI753WB2F1MMINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XMINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
Magnesium StearateINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
PovidoneINACTIVE INGREDIENTFZ989GH94EMINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-637MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]8Legacy NDC, 2 package rows20191211_aec056cd-4f1f-4971-2bea-0b05ee028889.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
207364minocycline HCl 100 MG Oral TabletPSNaec056cd-4f1f-4971-2bea-0b05ee0288898
207362minocycline HCl 50 MG Oral TabletPSNaec056cd-4f1f-4971-2bea-0b05ee0288898
403840minocycline HCl 75 MG Oral TabletPSNaec056cd-4f1f-4971-2bea-0b05ee0288898
207364minocycline 100 MG Oral TabletSCDaec056cd-4f1f-4971-2bea-0b05ee0288898
207362minocycline 50 MG Oral TabletSCDaec056cd-4f1f-4971-2bea-0b05ee0288898
403840minocycline 75 MG Oral TabletSCDaec056cd-4f1f-4971-2bea-0b05ee0288898
207364minocycline (as minocycline hydrochloride) 100 MG Oral TabletSYaec056cd-4f1f-4971-2bea-0b05ee0288898
207362minocycline (as minocycline hydrochloride) 50 MG Oral TabletSYaec056cd-4f1f-4971-2bea-0b05ee0288898
403840minocycline (as minocycline hydrochloride) 75 MG Oral TabletSYaec056cd-4f1f-4971-2bea-0b05ee0288898

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55111-637-0155111063701100 TABLET, FILM COATED in 1 BOTTLE (55111-637-01) 2008-01-230000-00-00NoNoCurrent
55111-637-10551110637101000 TABLET, FILM COATED in 1 BOTTLE (55111-637-10) 2008-01-230000-00-00NoNoCurrent