FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
63629-9213
11-digit product format
636299213
Labeler code
63629
Product ID
63629-9213_931b98ea-4357-4202-90a6-20521845b250
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
65 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 HYDROCHLORIDE65 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0020414E5U
Rxcui858372

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
63629-9213-1Minocycline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE30106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9213-1EA - Each63629-921333094d9e-d8ef-43a7-aac0-e196498f1a4512022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9213MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 1 package rows20240822_dddad9bc-a0a3-41bf-81e5-65d9903b14c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858372minocycline HCl 65 MG 24HR Extended Release Oral TabletPSNdddad9bc-a0a3-41bf-81e5-65d9903b14c6106
85837224 HR minocycline 65 MG Extended Release Oral TabletSCDdddad9bc-a0a3-41bf-81e5-65d9903b14c6106
858372minocycline 65 MG (as minocycline hydrochloride) 24 HR Extended Release Oral TabletSYdddad9bc-a0a3-41bf-81e5-65d9903b14c6106
858372minocycline 65 MG 24 HR Extended Release Oral TabletSYdddad9bc-a0a3-41bf-81e5-65d9903b14c6106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-9213-16362992130130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-9213-1) 2022-03-020000-00-00NoNoCurrent