Minocycline Hydrochloride

Product NDC
68788-7052
11-digit product format
687887052
Labeler code
68788
Product ID
68788-7052_34f81c26-d31d-4ff8-b581-59dc2074f297
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA065470
Marketing category
ANDA
Marketing start
2017-11-06
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
68788-7052-1Minocycline Hydrochloride14 in 1 BOTTLECAPSULE148
68788-7052-2Minocycline Hydrochloride20 in 1 BOTTLECAPSULE208
68788-7052-3Minocycline Hydrochloride30 in 1 BOTTLECAPSULE308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7052MINOCYCLINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 3 package rows20240719_caa99901-467c-4e99-b7e9-fbabdf5d118c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197984minocycline HCl 100 MG Oral CapsulePSNcaa99901-467c-4e99-b7e9-fbabdf5d118c8
197984minocycline 100 MG Oral CapsuleSCDcaa99901-467c-4e99-b7e9-fbabdf5d118c8
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYcaa99901-467c-4e99-b7e9-fbabdf5d118c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7052-16878870520114 CAPSULE in 1 BOTTLE (68788-7052-1) 14 capsule2017-11-060000-00-00NoNoCurrent
68788-7052-26878870520220 CAPSULE in 1 BOTTLE (68788-7052-2) 20 capsule2017-11-060000-00-00NoNoCurrent
68788-7052-36878870520330 CAPSULE in 1 BOTTLE (68788-7052-3) 30 capsule2017-11-060000-00-00NoNoCurrent