Minocycline Hydrochloride

Product NDC
68071-3635
11-digit product format
680713635
Labeler code
68071
Product ID
68071-3635_2abca736-08a4-e465-e063-6294a90a0b52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065062
Marketing category
ANDA
Marketing start
2015-04-02
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0020414E5U
Rxcui197985

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
68071-3635-3Minocycline Hydrochloride30 in 1 BOTTLECAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3635MINOCYCLINE HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250104_1c363cbb-099b-7c73-e063-6394a90ae13f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197985minocycline HCl 50 MG Oral CapsulePSN1c363cbb-099b-7c73-e063-6394a90ae13f2
197985minocycline 50 MG Oral CapsuleSCD1c363cbb-099b-7c73-e063-6394a90ae13f2
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSY1c363cbb-099b-7c73-e063-6394a90ae13f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3635-36807136350330 CAPSULE in 1 BOTTLE (68071-3635-3) 30 capsule2024-07-01NoNoHistorical