FDA.reportPublic FDA data

Minocycline Hydrochloride

Product NDC
60687-336
11-digit product format
606870336
Labeler code
60687
Product ID
60687-336_3ac2617e-b1b1-1cda-e063-6394a90aeca4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA065062
Marketing category
ANDA
Marketing start
2018-02-01
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0020414E5U
Rxcui197984

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
60687-336-11Minocycline Hydrochloride1 in 1 BLISTER PACKCAPSULE18
60687-336-65Minocycline Hydrochloride50 in 1 BOX, UNIT-DOSECAPSULE508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-336-11EA - Each60687-33672c17fd0-6cd6-4f27-89e1-a74604523fbe12018-03-08
60687-336-65EA - Each60687-336772f7516-3d8d-45f3-83e0-6463a7d285f212018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-336MINOCYCLINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 2 package rows20240906_94d941e3-d3d8-4414-bd5c-4a92848e738f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSN94d941e3-d3d8-4414-bd5c-4a92848e738f8
197984minocycline 100 MG Oral CapsuleSCD94d941e3-d3d8-4414-bd5c-4a92848e738f8
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSY94d941e3-d3d8-4414-bd5c-4a92848e738f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-336-11606870336111 in 1 BLISTER PACKHistorical
60687-336-656068703366550 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-336-65) / 1 CAPSULE in 1 BLISTER PACK (60687-336-11) 50 blister pack2018-02-010000-00-00NoNoCurrent