FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
68180-460
11-digit product format
681800460
Labeler code
68180
Product ID
68180-460_ad320f99-9382-4ef0-b6b6-86542020555a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA091424
Marketing category
ANDA
Marketing start
2019-02-22
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
55 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 HYDROCHLORIDE55 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0020414E5U
Rxcui629695, 629697, 629699, 1013662

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
68180-460-01Minocycline Hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE10012
68180-460-06Minocycline Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-460-06EA - Each68180-4601ca8af9d-5943-4072-bad8-08b012369bc712019-03-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]3
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UMINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-460MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]12Current NDC, Legacy NDC, 2 package rows20231102_3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
629695minocycline HCl 135 MG 24HR Extended Release Oral TabletPSN3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b12
629697minocycline HCl 45 MG 24HR Extended Release Oral TabletPSN3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b12
1013662minocycline HCl 55 MG 24HR Extended Release Oral TabletPSN3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b12
629699minocycline HCl 90 MG 24HR Extended Release Oral TabletPSN3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b12
62969524 HR minocycline 135 MG Extended Release Oral TabletSCD3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b12
62969724 HR minocycline 45 MG Extended Release Oral TabletSCD3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b12
101366224 HR minocycline 55 MG Extended Release Oral TabletSCD3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b12
62969924 HR minocycline 90 MG Extended Release Oral TabletSCD3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b12
629695minocycline 135 MG (as minocycline hydrochloride) 24 HR Extended Release Oral TabletSY3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b12
629695minocycline 135 MG 24 HR Extended Release Oral TabletSY3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b12
629697minocycline 45 MG (as minocycline hydrochloride) 24 HR Extended Release Oral TabletSY3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b12
629697minocycline 45 MG 24 HR Extended Release Oral TabletSY3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b12
1013662minocycline 55 MG 24 HR Extended Release Oral TabletSY3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b12
629699minocycline 90 MG (as minocycline hydrochloride) 24 HR Extended Release Oral TabletSY3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b12
629699minocycline 90 MG 24 HR Extended Release Oral TabletSY3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-460-0168180046001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-460-01) 2019-02-220000-00-00NoNoCurrent
68180-460-066818004600630 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-460-06) 2019-02-220000-00-00NoNoCurrent