FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
13668-484
11-digit product format
136680484
Labeler code
13668
Product ID
13668-484_4ee4f6d7-55da-406d-9a32-de923b01c15c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA065062
Marketing category
ANDA
Marketing start
2015-04-02
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Minocycline Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOCYCLINE HYDROCHLORIDE100 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
13668-484-05Minocycline Hydrochloride500 in 1 BOTTLECAPSULE50015
13668-484-50Minocycline Hydrochloride50 in 1 BOTTLECAPSULE5015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-484-05EA - Each13668-484459a8344-2015-436f-ac1c-694ce87b17e512016-03-04
13668-484-50EA - Each13668-4843d8b7a6b-c518-41a4-8b43-f3002f613bc312016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
GELATININACTIVE INGREDIENT2G86QN327LMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
SHELLACINACTIVE INGREDIENT46N107B71OMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-484MINOCYCLINE HYDROCHLORIDE CAPSULE [TORRENT PHARMACEUTICALS LIMITED]14Current NDC, Legacy NDC, 2 package rows20250508_55df55fb-18ec-4e00-9ed0-10bba0da513b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSN6b2a7493-2e6c-4901-b697-17eb188cc8dd100
197984minocycline 100 MG Oral CapsuleSCD6b2a7493-2e6c-4901-b697-17eb188cc8dd100
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY6b2a7493-2e6c-4901-b697-17eb188cc8dd100
197984minocycline HCl 100 MG Oral CapsulePSN7e2390b7-242c-43ff-afb3-b0a5e79351d327
197984minocycline 100 MG Oral CapsuleSCD7e2390b7-242c-43ff-afb3-b0a5e79351d327
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY7e2390b7-242c-43ff-afb3-b0a5e79351d327
197984minocycline HCl 100 MG Oral CapsulePSNc7d0226e-5ac5-4fb1-9849-9d6663a2e8ad18
197985minocycline HCl 50 MG Oral CapsulePSNc7d0226e-5ac5-4fb1-9849-9d6663a2e8ad18
197984minocycline 100 MG Oral CapsuleSCDc7d0226e-5ac5-4fb1-9849-9d6663a2e8ad18
197985minocycline 50 MG Oral CapsuleSCDc7d0226e-5ac5-4fb1-9849-9d6663a2e8ad18
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYc7d0226e-5ac5-4fb1-9849-9d6663a2e8ad18
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSYc7d0226e-5ac5-4fb1-9849-9d6663a2e8ad18
197984minocycline HCl 100 MG Oral CapsulePSN55df55fb-18ec-4e00-9ed0-10bba0da513b15
197985minocycline HCl 50 MG Oral CapsulePSN55df55fb-18ec-4e00-9ed0-10bba0da513b15
314108minocycline HCl 75 MG Oral CapsulePSN55df55fb-18ec-4e00-9ed0-10bba0da513b15
197984minocycline 100 MG Oral CapsuleSCD55df55fb-18ec-4e00-9ed0-10bba0da513b15
197985minocycline 50 MG Oral CapsuleSCD55df55fb-18ec-4e00-9ed0-10bba0da513b15
314108minocycline 75 MG Oral CapsuleSCD55df55fb-18ec-4e00-9ed0-10bba0da513b15
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY55df55fb-18ec-4e00-9ed0-10bba0da513b15
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSY55df55fb-18ec-4e00-9ed0-10bba0da513b15
314108minocycline (as minocycline hydrochloride) 75 MG Oral CapsuleSY55df55fb-18ec-4e00-9ed0-10bba0da513b15
197984minocycline HCl 100 MG Oral CapsulePSN65767ae3-b1ed-4492-90f2-703b2c7e0f3811
197984minocycline 100 MG Oral CapsuleSCD65767ae3-b1ed-4492-90f2-703b2c7e0f3811
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY65767ae3-b1ed-4492-90f2-703b2c7e0f3811
197984minocycline HCl 100 MG Oral CapsulePSN94d941e3-d3d8-4414-bd5c-4a92848e738f8
197984minocycline 100 MG Oral CapsuleSCD94d941e3-d3d8-4414-bd5c-4a92848e738f8
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY94d941e3-d3d8-4414-bd5c-4a92848e738f8
197984minocycline HCl 100 MG Oral CapsulePSN25c33cb5-4244-3721-e054-00144ff8d46c7
197984minocycline 100 MG Oral CapsuleSCD25c33cb5-4244-3721-e054-00144ff8d46c7
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY25c33cb5-4244-3721-e054-00144ff8d46c7
197984minocycline HCl 100 MG Oral CapsulePSNb4f98f74-198c-4745-a2b6-4e588898e79f5
197984minocycline HCl 100 MG Oral CapsulePSNfd86ff45-37d0-4501-b9fb-e1836e4a8be45
197984minocycline 100 MG Oral CapsuleSCDb4f98f74-198c-4745-a2b6-4e588898e79f5
197984minocycline 100 MG Oral CapsuleSCDfd86ff45-37d0-4501-b9fb-e1836e4a8be45
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYfd86ff45-37d0-4501-b9fb-e1836e4a8be45
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYb4f98f74-198c-4745-a2b6-4e588898e79f5
197984minocycline HCl 100 MG Oral CapsulePSNd67e4b17-7d44-4d72-9150-420d98cc6db33
197984minocycline HCl 100 MG Oral CapsulePSNec93ad27-aff5-cbc7-e053-2a95a90adc7e3
197984minocycline HCl 100 MG Oral CapsulePSN3bdc5afb-63dc-4313-e054-00144ff8d46c3
197984minocycline 100 MG Oral CapsuleSCDd67e4b17-7d44-4d72-9150-420d98cc6db33
197984minocycline 100 MG Oral CapsuleSCDec93ad27-aff5-cbc7-e053-2a95a90adc7e3
197984minocycline 100 MG Oral CapsuleSCD3bdc5afb-63dc-4313-e054-00144ff8d46c3
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYd67e4b17-7d44-4d72-9150-420d98cc6db33
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYec93ad27-aff5-cbc7-e053-2a95a90adc7e3
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY3bdc5afb-63dc-4313-e054-00144ff8d46c3
197984minocycline HCl 100 MG Oral CapsulePSNf901a1ba-1716-8795-e053-6294a90a4e772
197984minocycline 100 MG Oral CapsuleSCDf901a1ba-1716-8795-e053-6294a90a4e772
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYf901a1ba-1716-8795-e053-6294a90a4e772

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-484-0513668048405500 CAPSULE in 1 BOTTLE (13668-484-05) 500 capsule2015-04-020000-00-00NoNoCurrent
13668-484-501366804845050 CAPSULE in 1 BOTTLE (13668-484-50) 50 capsule2015-04-020000-00-00NoNoCurrent