FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
13668-482
11-digit product format
136680482
Labeler code
13668
Product ID
13668-482_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
50 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 HYDROCHLORIDE50 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
13668-482-01Minocycline Hydrochloride100 in 1 BOTTLECAPSULE10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-482-01EA - Each13668-48265a5b312-92c3-4ae3-958a-c55e3b97023f12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-482MINOCYCLINE HYDROCHLORIDE CAPSULE [TORRENT PHARMACEUTICALS LIMITED]14Current NDC, Legacy NDC, 1 package rows20250508_55df55fb-18ec-4e00-9ed0-10bba0da513b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197985minocycline HCl 50 MG Oral CapsulePSN093ff3c7-3ecc-47b4-9ae6-5218bcd262b2100
197985minocycline 50 MG Oral CapsuleSCD093ff3c7-3ecc-47b4-9ae6-5218bcd262b2100
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSY093ff3c7-3ecc-47b4-9ae6-5218bcd262b2100
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
197985minocycline HCl 50 MG Oral CapsulePSN1c363cbb-099b-7c73-e063-6394a90ae13f2
197985minocycline 50 MG Oral CapsuleSCD1c363cbb-099b-7c73-e063-6394a90ae13f2
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSY1c363cbb-099b-7c73-e063-6394a90ae13f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-482-0113668048201100 CAPSULE in 1 BOTTLE (13668-482-01) 100 capsule2015-04-020000-00-00NoNoCurrent