Minocycline Hydrochloride

Product NDC
63629-5327
11-digit product format
636295327
Labeler code
63629
Product ID
63629-5327_6880f216-6721-42de-bb21-29a20acd6dde
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA063065
Marketing category
ANDA
Marketing start
1999-06-10
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
75 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 HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0020414E5U
Rxcui314108

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
63629-5327-1Minocycline Hydrochloride30 in 1 BOTTLECAPSULE301003
63629-5327-2Minocycline Hydrochloride60 in 1 BOTTLECAPSULE601003
63629-5327-3Minocycline Hydrochloride16 in 1 BOTTLECAPSULE161003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1000
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1000
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1000
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1000
GELATININACTIVE INGREDIENT2G86QN327LMINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1000
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5327MINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1003Current NDC, 3 package rows20240906_6f154720-706e-4177-8167-1bc893303f1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314108minocycline HCl 75 MG Oral CapsulePSN6f154720-706e-4177-8167-1bc893303f1b1003
314108minocycline 75 MG Oral CapsuleSCD6f154720-706e-4177-8167-1bc893303f1b1003
314108minocycline (as minocycline hydrochloride) 75 MG Oral CapsuleSY6f154720-706e-4177-8167-1bc893303f1b1003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-5327-16362953270130 CAPSULE in 1 BOTTLE (63629-5327-1) 30 capsule2014-05-02NoNoCurrent
63629-5327-26362953270260 CAPSULE in 1 BOTTLE (63629-5327-2) 60 capsule2014-05-02NoNoCurrent
63629-5327-36362953270316 CAPSULE in 1 BOTTLE (63629-5327-3) 16 capsule2014-05-02NoNoCurrent