FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
71335-0682
11-digit product format
713350682
Labeler code
71335
Product ID
71335-0682_034b4afb-e15a-454e-a13a-8a1397856a53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA063181
Marketing category
ANDA
Marketing start
1992-02-01
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0020414E5U
Rxcui197984, 197985

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
71335-0682-1Minocycline Hydrochloride90 in 1 BOTTLECAPSULE902
71335-0682-2Minocycline Hydrochloride50 in 1 BOTTLECAPSULE502
71335-0682-3Minocycline Hydrochloride60 in 1 BOTTLECAPSULE602
71335-0682-4Minocycline Hydrochloride30 in 1 BOTTLECAPSULE302
71335-0682-5Minocycline Hydrochloride100 in 1 BOTTLECAPSULE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0682MINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]2Current NDC, Legacy NDC, 5 package rows20190614_a84c29a9-21a8-4965-b5a5-37b28e4af5a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSNa84c29a9-21a8-4965-b5a5-37b28e4af5a02
197985minocycline HCl 50 MG Oral CapsulePSNa84c29a9-21a8-4965-b5a5-37b28e4af5a02
197984minocycline 100 MG Oral CapsuleSCDa84c29a9-21a8-4965-b5a5-37b28e4af5a02
197985minocycline 50 MG Oral CapsuleSCDa84c29a9-21a8-4965-b5a5-37b28e4af5a02
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYa84c29a9-21a8-4965-b5a5-37b28e4af5a02
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSYa84c29a9-21a8-4965-b5a5-37b28e4af5a02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0682-17133506820190 CAPSULE in 1 BOTTLE (71335-0682-1) 90 capsule2015-09-170000-00-00NoNoCurrent
71335-0682-27133506820250 CAPSULE in 1 BOTTLE (71335-0682-2) 50 capsule2015-09-170000-00-00NoNoCurrent
71335-0682-37133506820360 CAPSULE in 1 BOTTLE (71335-0682-3) 60 capsule2015-09-170000-00-00NoNoCurrent
71335-0682-47133506820430 CAPSULE in 1 BOTTLE (71335-0682-4) 30 capsule2015-09-170000-00-00NoNoCurrent
71335-0682-571335068205100 CAPSULE in 1 BOTTLE (71335-0682-5) 100 capsule2015-09-170000-00-00NoNoCurrent