Minocycline Hydrochloride

Product NDC
53002-2210
11-digit product format
530022210
Labeler code
53002
Product ID
53002-2210_da36bb4f-82aa-413a-9e94-9b05226e1581
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA065062
Marketing category
ANDA
Marketing start
2015-04-02
Marketing end
0000-00-00
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
0020414E5UMINOCYCLINE HYDROCHLORIDE13614-98-7MINOCYCLINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2210-35300222100330 CAPSULE in 1 BOTTLE (53002-2210-3) 30 capsule2018-10-010000-00-00NoNoCurrent
53002-2210-45300222100414 CAPSULE in 1 BOTTLE (53002-2210-4) 14 capsule2018-10-010000-00-00NoNoCurrent
53002-2210-65300222100660 CAPSULE in 1 BOTTLE (53002-2210-6) 60 capsule2018-10-010000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
MINOCYCLINE HYDROCHLORIDE CAPSULES, USP Rx onlyRPK Pharmaceuticals, Inc.2023-06-07HUMAN PRESCRIPTION DRUG LABEL5