FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
63629-9209
11-digit product format
636299209
Labeler code
63629
Product ID
63629-9209_b2f91767-0691-432b-965a-98d34f35fa44
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204453
Marketing category
ANDA
Marketing start
2016-09-30
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
115 mg/1
Pharmacologic classes
Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Minocycline Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOCYCLINE HYDROCHLORIDE115 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0020414E5U
Rxcui858062

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
63629-9209-1Minocycline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE30105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9209MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240711_9c43389b-dc98-41f3-80bf-73d916ad6843.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858062minocycline HCl 115 MG 24HR Extended Release Oral TabletPSN9c43389b-dc98-41f3-80bf-73d916ad6843105
85806224 HR minocycline 115 MG Extended Release Oral TabletSCD9c43389b-dc98-41f3-80bf-73d916ad6843105
858062minocycline 115 MG (as minocycline hydrochloride) 24 HR Extended Release Oral TabletSY9c43389b-dc98-41f3-80bf-73d916ad6843105
858062minocycline 115 MG 24 HR Extended Release Oral TabletSY9c43389b-dc98-41f3-80bf-73d916ad6843105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-9209-16362992090130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-9209-1) 2022-03-020000-00-00NoNoCurrent