FDA.reportPublic FDA data

minocycline hydrochloride

Product NDC
68382-552
11-digit product format
683820552
Labeler code
68382
Product ID
68382-552_d984bc89-8412-45fd-ba75-e707bc53ae3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
minocycline hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA203553
Marketing category
ANDA
Marketing start
2018-03-07
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
105 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 HYDROCHLORIDE105 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0020414E5U
Rxcui629695, 629697, 629699, 858062, 858372, 1013659, 1013662, 1013665

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9c90ddb-dcc8-42af-a94b-505e4488bdc7Product name120250623
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
23de08d7-aa4e-ec8b-ce6d-2124a855e4efProduct name520180605
76736e48-254d-4a39-993d-206efbdaad1dProduct name120170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
0c498039-5512-d9d7-e6b6-833de47219ffProduct name220151106
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-552-01minocycline hydrochloride100 in 1 BOTTLETABLET, EXTENDED RELEASE1005
68382-552-05minocycline hydrochloride500 in 1 BOTTLETABLET, EXTENDED RELEASE5005
68382-552-06minocycline hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE305
68382-552-10minocycline hydrochloride1000 in 1 BOTTLETABLET, EXTENDED RELEASE10005
68382-552-16minocycline hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE905
68382-552-30minocycline hydrochloride10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE105
68382-552-30minocycline hydrochloride10 in 1 CARTONTABLET, EXTENDED RELEASE105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-552MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]2Current NDC, Legacy NDC, 7 package rows20191228_85f082a5-bba1-4441-ba28-4b8ec9a537f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1013659minocycline HCl 105 MG 24HR Extended Release Oral TabletPSN85f082a5-bba1-4441-ba28-4b8ec9a537f25
858062minocycline HCl 115 MG 24HR Extended Release Oral TabletPSN85f082a5-bba1-4441-ba28-4b8ec9a537f25
629695minocycline HCl 135 MG 24HR Extended Release Oral TabletPSN85f082a5-bba1-4441-ba28-4b8ec9a537f25
629697minocycline HCl 45 MG 24HR Extended Release Oral TabletPSN85f082a5-bba1-4441-ba28-4b8ec9a537f25
1013662minocycline HCl 55 MG 24HR Extended Release Oral TabletPSN85f082a5-bba1-4441-ba28-4b8ec9a537f25
858372minocycline HCl 65 MG 24HR Extended Release Oral TabletPSN85f082a5-bba1-4441-ba28-4b8ec9a537f25
1013665minocycline HCl 80 MG 24HR Extended Release Oral TabletPSN85f082a5-bba1-4441-ba28-4b8ec9a537f25
629699minocycline HCl 90 MG 24HR Extended Release Oral TabletPSN85f082a5-bba1-4441-ba28-4b8ec9a537f25
101365924 HR minocycline 105 MG Extended Release Oral TabletSCD85f082a5-bba1-4441-ba28-4b8ec9a537f25
85806224 HR minocycline 115 MG Extended Release Oral TabletSCD85f082a5-bba1-4441-ba28-4b8ec9a537f25
62969524 HR minocycline 135 MG Extended Release Oral TabletSCD85f082a5-bba1-4441-ba28-4b8ec9a537f25
62969724 HR minocycline 45 MG Extended Release Oral TabletSCD85f082a5-bba1-4441-ba28-4b8ec9a537f25
101366224 HR minocycline 55 MG Extended Release Oral TabletSCD85f082a5-bba1-4441-ba28-4b8ec9a537f25
85837224 HR minocycline 65 MG Extended Release Oral TabletSCD85f082a5-bba1-4441-ba28-4b8ec9a537f25
101366524 HR minocycline 80 MG Extended Release Oral TabletSCD85f082a5-bba1-4441-ba28-4b8ec9a537f25
62969924 HR minocycline 90 MG Extended Release Oral TabletSCD85f082a5-bba1-4441-ba28-4b8ec9a537f25
1013659minocycline 105 MG (26.25 MG Immediate Release Beads / 78.75 MG Extended Release Beads) 24 HR Extended Release Oral TabletSY85f082a5-bba1-4441-ba28-4b8ec9a537f25
1013659minocycline 105 MG (as minocycline HCl 113.4 MG) 24 HR Extended Release Oral TabletSY85f082a5-bba1-4441-ba28-4b8ec9a537f25
1013659minocycline 105 MG 24 HR Extended Release Oral TabletSY85f082a5-bba1-4441-ba28-4b8ec9a537f25
858062minocycline 115 MG (as minocycline hydrochloride) 24 HR Extended Release Oral TabletSY85f082a5-bba1-4441-ba28-4b8ec9a537f25
858062minocycline 115 MG 24 HR Extended Release Oral TabletSY85f082a5-bba1-4441-ba28-4b8ec9a537f25
629695minocycline 135 MG (as minocycline hydrochloride) 24 HR Extended Release Oral TabletSY85f082a5-bba1-4441-ba28-4b8ec9a537f25
629695minocycline 135 MG 24 HR Extended Release Oral TabletSY85f082a5-bba1-4441-ba28-4b8ec9a537f25
629697minocycline 45 MG (as minocycline hydrochloride) 24 HR Extended Release Oral TabletSY85f082a5-bba1-4441-ba28-4b8ec9a537f25
629697minocycline 45 MG 24 HR Extended Release Oral TabletSY85f082a5-bba1-4441-ba28-4b8ec9a537f25
1013662minocycline 55 MG 24 HR Extended Release Oral TabletSY85f082a5-bba1-4441-ba28-4b8ec9a537f25
858372minocycline 65 MG (as minocycline hydrochloride) 24 HR Extended Release Oral TabletSY85f082a5-bba1-4441-ba28-4b8ec9a537f25
858372minocycline 65 MG 24 HR Extended Release Oral TabletSY85f082a5-bba1-4441-ba28-4b8ec9a537f25
1013665minocycline 80 MG 24 HR Extended Release Oral TabletSY85f082a5-bba1-4441-ba28-4b8ec9a537f25
629699minocycline 90 MG (as minocycline hydrochloride) 24 HR Extended Release Oral TabletSY85f082a5-bba1-4441-ba28-4b8ec9a537f25
629699minocycline 90 MG 24 HR Extended Release Oral TabletSY85f082a5-bba1-4441-ba28-4b8ec9a537f25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-552-0168382055201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-01) 2018-03-070000-00-00NoNoCurrent
68382-552-0568382055205500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-05) 2018-03-070000-00-00NoNoCurrent
68382-552-066838205520630 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-06) 2018-03-070000-00-00NoNoCurrent
68382-552-10683820552101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-10) 2018-03-070000-00-00NoNoCurrent
68382-552-166838205521690 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-552-16) 2018-03-070000-00-00NoNoCurrent
68382-552-306838205523010 BLISTER PACK in 1 CARTON (68382-552-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2018-03-070000-00-00NoNoCurrent