FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
51655-004
11-digit product format
516550004
Labeler code
51655
Product ID
51655-004_49890ea1-320e-ba0a-e063-6394a90a3fff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA065470
Marketing category
ANDA
Marketing start
2014-08-20
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9c90ddb-dcc8-42af-a94b-505e4488bdc7Product name120250623
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
23de08d7-aa4e-ec8b-ce6d-2124a855e4efProduct name520180605
76736e48-254d-4a39-993d-206efbdaad1dProduct name120170717
0c498039-5512-d9d7-e6b6-833de47219ffProduct name220151106

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-004-522024-07-02C16284748780-19d75b9d0-7417-f424-e053-dadaa90a57ceMinocycline Hydrochloride Capsules, USP Rx only
51655-004-522020-01-31C16284748780-19d75b9d0-7417-f424-e053-dadaa90a57ceMinocycline Hydrochloride Capsules, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-004-20Minocycline Hydrochloride20 in 1 BOTTLE, PLASTICCAPSULE205
51655-004-52Minocycline Hydrochloride30 in 1 BOTTLE, DISPENSINGCAPSULE305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]1
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-004MINOCYCLINE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20241215_12559b29-6568-4b99-a16e-6a87038981f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSN12559b29-6568-4b99-a16e-6a87038981f75
197984minocycline 100 MG Oral CapsuleSCD12559b29-6568-4b99-a16e-6a87038981f75
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY12559b29-6568-4b99-a16e-6a87038981f75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-004-205165500042020 CAPSULE in 1 BOTTLE, PLASTIC (51655-004-20) 20 capsule2025-03-13NoNoCurrent
51655-004-525165500045230 CAPSULE in 1 BOTTLE, DISPENSING (51655-004-52) 30 capsule2014-08-20NoNoCurrent