FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
59651-338
11-digit product format
596510338
Labeler code
59651
Product ID
59651-338_2ef3b8ae-dd97-473f-bd81-c8c1b192c0ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA213662
Marketing category
ANDA
Marketing start
2020-05-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Minocycline Hydrochloride
Listing expiration
2026-12-31

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
59651-338-01Minocycline Hydrochloride100 in 1 CONTAINERTABLET, FILM COATED1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-338MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]3Current NDC, Legacy NDC, 1 package rows20250105_799a9871-3249-471e-b88d-5d8f7d4b96ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
207364minocycline HCl 100 MG Oral TabletPSN799a9871-3249-471e-b88d-5d8f7d4b96ad3
207362minocycline HCl 50 MG Oral TabletPSN799a9871-3249-471e-b88d-5d8f7d4b96ad3
403840minocycline HCl 75 MG Oral TabletPSN799a9871-3249-471e-b88d-5d8f7d4b96ad3
207364minocycline 100 MG Oral TabletSCD799a9871-3249-471e-b88d-5d8f7d4b96ad3
207362minocycline 50 MG Oral TabletSCD799a9871-3249-471e-b88d-5d8f7d4b96ad3
403840minocycline 75 MG Oral TabletSCD799a9871-3249-471e-b88d-5d8f7d4b96ad3
207364minocycline (as minocycline hydrochloride) 100 MG Oral TabletSY799a9871-3249-471e-b88d-5d8f7d4b96ad3
207362minocycline (as minocycline hydrochloride) 50 MG Oral TabletSY799a9871-3249-471e-b88d-5d8f7d4b96ad3
403840minocycline (as minocycline hydrochloride) 75 MG Oral TabletSY799a9871-3249-471e-b88d-5d8f7d4b96ad3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59651-338-0159651033801100 TABLET, FILM COATED in 1 CONTAINER (59651-338-01) 2020-05-010000-00-00NoNoCurrent
59651-338-27596510338272800 TABLET, FILM COATED in 1 BAG (59651-338-27)01-MAY-20Current