FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
50090-3016
11-digit product format
500903016
Labeler code
50090
Product ID
50090-3016_30520cba-5198-4c93-a802-996472116eed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065470
Marketing category
ANDA
Marketing start
2008-03-11
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
Rxcui197984, 197985

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
50090-3016-02024-01-29C16284748780-1f386c649-beff-0266-e053-dadaa90a7c1aMinocycline Hydrochloride Capsules, USP Rx only
50090-3016-32024-01-29C16284748780-1f386c649-beff-0266-e053-dadaa90a7c1aMinocycline Hydrochloride Capsules, USP Rx only
50090-3016-02023-01-30C16284748780-1f386c649-beff-0266-e053-dadaa90a7c1aMinocycline Hydrochloride Capsules, USP Rx only
50090-3016-32023-01-30C16284748780-1f386c649-beff-0266-e053-dadaa90a7c1aMinocycline Hydrochloride Capsules, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3016-0Minocycline Hydrochloride60 in 1 BOTTLECAPSULE6028
50090-3016-3Minocycline Hydrochloride90 in 1 BOTTLECAPSULE9028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3016-0EA - Each50090-301655e766e7-eed4-474a-9141-3f51c4059d7212019-05-02
50090-3016-3EA - Each50090-301612e2af46-4e70-4a4b-a6be-e25a28ea98fa12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3016MINOCYCLINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]26Current NDC, Legacy NDC, 2 package rows20240201_c96b1c5d-7004-4ee2-ad48-0ba963389f86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSNc96b1c5d-7004-4ee2-ad48-0ba963389f8628
197985minocycline HCl 50 MG Oral CapsulePSNc96b1c5d-7004-4ee2-ad48-0ba963389f8628
197984minocycline 100 MG Oral CapsuleSCDc96b1c5d-7004-4ee2-ad48-0ba963389f8628
197985minocycline 50 MG Oral CapsuleSCDc96b1c5d-7004-4ee2-ad48-0ba963389f8628
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYc96b1c5d-7004-4ee2-ad48-0ba963389f8628
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSYc96b1c5d-7004-4ee2-ad48-0ba963389f8628

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3016-05009030160060 CAPSULE in 1 BOTTLE (50090-3016-0) 60 capsule2017-07-260000-00-00NoNoCurrent
50090-3016-35009030160390 CAPSULE in 1 BOTTLE (50090-3016-3) 90 capsule2017-05-120000-00-00NoNoCurrent