FDA.reportPublic FDA data

MINOCYCLINE HYDROCHLORIDE

Product NDC
61919-270
11-digit product format
619190270
Labeler code
61919
Product ID
61919-270_e1a5a537-912e-cd05-e053-2995a90a45b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MINOCYCLINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
DirectRX
Application
ANDA065062
Marketing category
ANDA
Marketing start
2018-03-14
Marketing end
0000-00-00
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
61919-270-202025-01-30C16284748780-12cef2736-8b00-d83d-e063-dadaa90ab31fMINOCYCLINE HYDROCHLORIDE
61919-270-302025-01-30C16284748780-12cef2736-8b00-d83d-e063-dadaa90ab31fMINOCYCLINE HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-270-20MINOCYCLINE HYDROCHLORIDE20 in 1 BOTTLECAPSULE207
61919-270-30MINOCYCLINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-270-20EA - Each61919-270150d4e37-6b53-48e1-bf2b-f65c3b59d00612018-04-19
61919-270-30EA - Each61919-2702c3b3013-38d7-4180-ba07-99deb5d3233e12022-07-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
GELATININACTIVE INGREDIENT2G86QN327LMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
SHELLACINACTIVE INGREDIENT46N107B71OMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-270MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECTRX]7Legacy NDC, 2 package rows20230418_25c33cb5-4244-3721-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSN25c33cb5-4244-3721-e054-00144ff8d46c7
197984minocycline 100 MG Oral CapsuleSCD25c33cb5-4244-3721-e054-00144ff8d46c7
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY25c33cb5-4244-3721-e054-00144ff8d46c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-270-206191902702020 CAPSULE in 1 BOTTLE (61919-270-20) 20 capsule2018-03-140000-00-00NoNoCurrent
61919-270-306191902703030 CAPSULE in 1 BOTTLE (61919-270-30) 30 capsule2018-03-140000-00-00NoNoCurrent