FDA.reportPublic FDA data

Minolira Extended Release

Product NDC
71403-102
11-digit product format
714030102
Labeler code
71403
Product ID
71403-102_40cf85be-00c6-4c01-b09d-5d336eb55227
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
EPI Health, Inc
Application
NDA209269
Marketing category
NDA
Marketing start
2019-03-15
Marketing end
0000-00-00
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
135 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
71403-102-052023-07-28C16284748780-10191ceaa-63d3-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use MINOLIRA™ safely and effectively. See full prescribing information for MINOLIRA. MINOLIRA™ (minocycline hydrochloride) extended-release tablets, for oral use Initial U.S. Approval: 1971
71403-102-302023-07-28C16284748780-10191ceaa-63d3-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use MINOLIRA™ safely and effectively. See full prescribing information for MINOLIRA. MINOLIRA™ (minocycline hydrochloride) extended-release tablets, for oral use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71403-102-05Minolira Extended Release1 in 1 CARTONTABLET14
71403-102-05Minolira Extended Release5 in 1 BOTTLETABLET54
71403-102-30Minolira Extended Release30 in 1 BOTTLETABLET304
71403-102-30Minolira Extended Release1 in 1 CARTONTABLET14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71403-102-30EA - Each71403-1026b2eaac1-3d6c-4cc8-bc95-8de2f7edebf212019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71403-102MINOLIRA EXTENDED RELEASE (MINOCYCLINE HYDROCHLORIDE) TABLET [EPI HEALTH, INC]4Legacy NDC, 4 package rows20221208_523856a4-530b-4a23-a80a-d72ab08e2c08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1013659minocycline HCl 105 MG 24HR Extended Release Oral TabletPSN523856a4-530b-4a23-a80a-d72ab08e2c084
629695minocycline HCl 135 MG 24HR Extended Release Oral TabletPSN523856a4-530b-4a23-a80a-d72ab08e2c084
1941489minolira 105 MG 24HR Extended Release Oral TabletPSN523856a4-530b-4a23-a80a-d72ab08e2c084
2058529minolira 135 MG 24HR Extended Release Oral TabletPSN523856a4-530b-4a23-a80a-d72ab08e2c084
194148924 HR minocycline 105 MG Extended Release Oral Tablet [Minolira]SBD523856a4-530b-4a23-a80a-d72ab08e2c084
205852924 HR minocycline 135 MG Extended Release Oral Tablet [Minolira]SBD523856a4-530b-4a23-a80a-d72ab08e2c084
101365924 HR minocycline 105 MG Extended Release Oral TabletSCD523856a4-530b-4a23-a80a-d72ab08e2c084
62969524 HR minocycline 135 MG Extended Release Oral TabletSCD523856a4-530b-4a23-a80a-d72ab08e2c084
1013659minocycline 105 MG (26.25 MG Immediate Release Beads / 78.75 MG Extended Release Beads) 24 HR Extended Release Oral TabletSY523856a4-530b-4a23-a80a-d72ab08e2c084
1013659minocycline 105 MG (as minocycline HCl 113.4 MG) 24 HR Extended Release Oral TabletSY523856a4-530b-4a23-a80a-d72ab08e2c084
1013659minocycline 105 MG 24 HR Extended Release Oral TabletSY523856a4-530b-4a23-a80a-d72ab08e2c084
629695minocycline 135 MG (as minocycline hydrochloride) 24 HR Extended Release Oral TabletSY523856a4-530b-4a23-a80a-d72ab08e2c084
629695minocycline 135 MG 24 HR Extended Release Oral TabletSY523856a4-530b-4a23-a80a-d72ab08e2c084
1941489Minolira 105 MG (26.25 MG Immediate Release Beads / 78.75 MG Extended Release Beads) 24 HR Extended Release Oral TabletSY523856a4-530b-4a23-a80a-d72ab08e2c084
1941489Minolira 105 MG (as minocycline HCl 113.4 MG) 24 HR Extended Release Oral TabletSY523856a4-530b-4a23-a80a-d72ab08e2c084
1941489Minolira 105 MG 24 HR Extended Release Oral TabletSY523856a4-530b-4a23-a80a-d72ab08e2c084
2058529Minolira 135 MG 24 HR Extended Release Oral TabletSY523856a4-530b-4a23-a80a-d72ab08e2c084

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71403-102-05714030102051 BOTTLE in 1 CARTON (71403-102-05) > 5 TABLET in 1 BOTTLE1 bottle2019-03-150000-00-00NoNoCurrent
71403-102-30714030102301 BOTTLE in 1 CARTON (71403-102-30) > 30 TABLET in 1 BOTTLE1 bottle2019-03-150000-00-00NoNoCurrent