MINOCYCLINE HYDROCHLORIDE

Product NDC
13668-486
11-digit product format
136680486
Labeler code
13668
Product ID
13668-486_3bd2bae3-7b58-42f2-8fc2-9c036b8a476d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MINOCYCLINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA065156
Marketing category
ANDA
Marketing start
2015-04-02
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
75 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 HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0020414E5U
Rxcui207362, 207364, 403840

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
13668-486-01MINOCYCLINE HYDROCHLORIDE100 in 1 BOTTLETABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-486-01EA - Each13668-4865a20e739-317d-4e76-b3b4-4af754370e0312017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-486MINOCYCLINE HYDROCHLORIDE TABLET [TORRENT PHARMACEUTICALS LIMITED]10Current NDC, Legacy NDC, 1 package rows20250508_3539f84e-b489-4914-96c1-ac3731032971.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
207364minocycline HCl 100 MG Oral TabletPSN3539f84e-b489-4914-96c1-ac373103297111
207362minocycline HCl 50 MG Oral TabletPSN3539f84e-b489-4914-96c1-ac373103297111
403840minocycline HCl 75 MG Oral TabletPSN3539f84e-b489-4914-96c1-ac373103297111
207364minocycline 100 MG Oral TabletSCD3539f84e-b489-4914-96c1-ac373103297111
207362minocycline 50 MG Oral TabletSCD3539f84e-b489-4914-96c1-ac373103297111
403840minocycline 75 MG Oral TabletSCD3539f84e-b489-4914-96c1-ac373103297111
207364minocycline (as minocycline hydrochloride) 100 MG Oral TabletSY3539f84e-b489-4914-96c1-ac373103297111
207362minocycline (as minocycline hydrochloride) 50 MG Oral TabletSY3539f84e-b489-4914-96c1-ac373103297111
403840minocycline (as minocycline hydrochloride) 75 MG Oral TabletSY3539f84e-b489-4914-96c1-ac373103297111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-486-0113668048601100 TABLET in 1 BOTTLE (13668-486-01) 100 tablet2015-04-020000-00-00NoNoCurrent