FDA.reportPublic FDA data

Minocycline hydrochloride

Product NDC
51655-753
11-digit product format
516550753
Labeler code
51655
Product ID
51655-753_4a7ae1e2-034d-e158-e063-6394a90ad9e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA063011
Marketing category
ANDA
Marketing start
2023-01-24
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
Rxcui197985

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-753-202026-01-29C16284748780-149896155-a344-586f-e063-e6dba90add90Minocycline Hydrochloride Capsules, USP
51655-753-252026-01-29C16284748780-149896155-a344-586f-e063-e6dba90add90Minocycline Hydrochloride Capsules, USP
51655-753-262026-01-29C16284748780-149896155-a344-586f-e063-e6dba90add90Minocycline Hydrochloride Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-753-20Minocycline hydrochloride20 in 1 BOTTLE, PLASTICCAPSULE204
51655-753-25Minocycline hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE604
51655-753-26Minocycline hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-753MINOCYCLINE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 3 package rows20240127_f33fcfd2-b9ef-8e67-e053-2a95a90a0306.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197985minocycline HCl 50 MG Oral CapsulePSNf33fcfd2-b9ef-8e67-e053-2a95a90a03064
197985minocycline 50 MG Oral CapsuleSCDf33fcfd2-b9ef-8e67-e053-2a95a90a03064
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSYf33fcfd2-b9ef-8e67-e053-2a95a90a03064

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-753-205165507532020 CAPSULE in 1 BOTTLE, PLASTIC (51655-753-20) 20 capsule2023-03-06NoNoCurrent
51655-753-255165507532560 CAPSULE in 1 BOTTLE, PLASTIC (51655-753-25) 60 capsule2023-01-24NoNoCurrent
51655-753-265165507532690 CAPSULE in 1 BOTTLE, PLASTIC (51655-753-26) 90 capsule2023-07-19NoNoCurrent