FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
0904-6888
11-digit product format
009046888
Labeler code
0904
Product ID
0904-6888_aed0618f-2e64-4e18-991b-1e38efcf56b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharamceuticals
Application
ANDA065062
Marketing category
ANDA
Marketing start
2015-04-02
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Minocycline Hydrochloride
Listing expiration
2026-12-31

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6888-06Minocycline Hydrochloride1 in 1 BLISTER PACKCAPSULE15
0904-6888-06Minocycline Hydrochloride50 in 1 CARTONCAPSULE505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6888-06EA - Each0904-68880ff91820-e7b1-451a-b82c-2deaa2dae33512019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6888MINOCYCLINE HYDROCHLORIDE CAPSULE [MAJOR PHARAMCEUTICALS]4Current NDC, Legacy NDC, 2 package rows20250205_fd86ff45-37d0-4501-b9fb-e1836e4a8be4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSNfd86ff45-37d0-4501-b9fb-e1836e4a8be45
197984minocycline 100 MG Oral CapsuleSCDfd86ff45-37d0-4501-b9fb-e1836e4a8be45
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYfd86ff45-37d0-4501-b9fb-e1836e4a8be45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6888-060090468880650 BLISTER PACK in 1 CARTON (0904-6888-06) / 1 CAPSULE in 1 BLISTER PACK50 blister pack2015-04-020000-00-00NoNoCurrent