FDA.reportPublic FDA data

Arestin

Product NDC
65976-100
11-digit product format
659760100
Labeler code
65976
Product ID
65976-100_668385ee-9443-4d20-b0ea-655c2526ca96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
POWDER
Route
ORAL
Labeler
OraPharma, Inc.
Application
NDA050781
Marketing category
NDA
Marketing start
2011-03-21
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
1 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
Arestin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOCYCLINE HYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0020414E5U
Rxcui351121, 351974

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
65976-100-01Arestin1 in 1 POUCHPOWDER121
65976-100-12Arestin1 in 1 BOXPOWDER121
65976-100-12Arestin1 in 1 POUCHPOWDER121
65976-100-24Arestin1 in 1 POUCHPOWDER121
65976-100-24Arestin2 in 1 BOXPOWDER221

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65976-100-01EA - Each65976-100d9c98f75-a79b-448c-a2cc-506ae7b6abb912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Minocycline HydrochlorideACTIVE INGREDIENT0020414E5UARESTIN (MINOCYCLINE HYDROCHLORIDE) POWDER [ORAPHARMA, INC.]7
MinocyclineACTIVE MOIETYFYY3R43WGOARESTIN (MINOCYCLINE HYDROCHLORIDE) POWDER [ORAPHARMA, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65976-100ARESTIN (MINOCYCLINE HYDROCHLORIDE) POWDER [ORAPHARMA, INC.]21Current NDC, Legacy NDC, 5 package rows20240816_8515df41-1936-4f3b-86ba-d2bb2a8441fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351974Arestin 1 MG Oral PowderPSN8515df41-1936-4f3b-86ba-d2bb2a8441fb21
351121minocycline HCl 1 MG Oral PowderPSN8515df41-1936-4f3b-86ba-d2bb2a8441fb21
351974minocycline 1 MG Oral Powder [Arestin]SBD8515df41-1936-4f3b-86ba-d2bb2a8441fb21
351121minocycline 1 MG Oral PowderSCD8515df41-1936-4f3b-86ba-d2bb2a8441fb21
351974Arestin (minocycline hydrochloride) 1 MG Oral PowderSY8515df41-1936-4f3b-86ba-d2bb2a8441fb21
351974Arestin 1 MG Oral PowderSY8515df41-1936-4f3b-86ba-d2bb2a8441fb21
351121minocycline 1 MG (as minocycline hydrochloride) Oral PowderSY8515df41-1936-4f3b-86ba-d2bb2a8441fb21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65976-100-01659760100011 POWDER in 1 POUCH (65976-100-01) 1 powder2011-03-210000-00-00NoNoCurrent
65976-100-12659760100121 POUCH in 1 BOX (65976-100-12) / 1 TRAY in 1 POUCH / 12 POWDER in 1 TRAY1 pouch2011-03-210000-00-00NoNoCurrent
65976-100-24659760100242 POUCH in 1 BOX (65976-100-24) / 1 TRAY in 1 POUCH / 12 POWDER in 1 TRAY2 pouch2011-03-210000-00-00NoNoCurrent